Oklahoma bill seeks to make ivermectin an over the counter drug

An Oklahoma bill is being proposed which will allow medications such as Ivermectin to be purchased over the counter in the Sooner State.

The Bill is SB426 and is authored by Oklahoma Freedom Caucus Chairman Shane Jett (R-Shawnee).

The bill requires pharmacies in the state to make chloroquine, hydroxychloroquine and ivermectin over the counter drugs.

Ivermectin became world-wide known seemingly overnight during the COVID pandemic.

If a pharmacy or pharmacist does not make those drugs over the counter medicine, then the State Board of Pharmacy is to revoke their license immediately.

The bill has yet to be heard by a committee.

Chinese scientists identify food ingredient they say could reverse some autism symptoms

Scientists have identified a probiotic in dairy fermentation that may help alleviate and reverse some autism symptoms.

Currently patients can only use antipsychotics, antidepressants, stimulants and anti-anxiety medications for treatments, but the new study suggests a natural method could just as effective.

The discovery was made using genetically modified mice that were prone to autism-like symptoms.

When modified, the mice exhibited symptoms of the disorder like a reduced interest in social interactions and an imbalance in the key neurotransmitters crucial for functions like learning, memory and cognitive processes.

Researchers gave the animals a daily dose of the probiotic Lactobacillus murinus (a type of bacteria commonly found in dairy products like cheese and yogurt) for one month.

Following the experiment, the mice’s brains became more flexible and adaptable, which helped them learn and remember things better.

The treatment also led to recovery of the intestines and other genes that are impacted by the disorder.

Around one in 36 children has been diagnosed with autism spectrum disorder (ASD) in the US, according to the CDC’s most recent estimate.

What causes the disorder is unknown. Research has pointed to growing pollution and chemical contamination in food and water may allow toxins to infiltrate the bloodstream of pregnant mothers and travel to the brain of the developing fetus, causing inflammation that impairs nerve signals that lead to autism.

Most children cannot be diagnosed until at least four years old and the current treatments include behavioral and speech therapies.

But the Chinese scientists may have uncovered a treatment in common foods that could complement behavioral interventions with minimal side effects, they said.

The study used 34 mice that had 13 pairs from their CHD8 gene removed, which disrupted protein production, South China Morning Post reported.

The mice then began to show autism-like behaviors, including anxiety, problems with socializing and memory.

Other research has found that gut bacteria can impact brain functions through the gut-brain axis, the complex network of communication between the gastrointestinal tract and the central nervous system.

That led the team to test if Lactobacillus murinus could be a treatment for autism.

The probiotic is known for its anti‐inflammatory and antibacterial actions. It has also been found to ease depression.

The mice were given Lactobacillus murinus over the course of 30 days, allowing researchers to monitor their behavior and internal progress.

Not only did their social behaviors reverse, but the intestine started to return to normal.

A 2022 study conducted at China’s Zhujiang Hospital found underdeveloped intestines could be a significant factor in driving autism-related gut microbiota and behavioral issues.

The new research also found the excitatory/inhibitory (E/I) balance in the brain’s cortex showed a trend toward recovery.

This balance of neural activity in the brain involves excitation and inhibition and is a key factor in how the brain processes information and generates oscillatory activity.

Individuals with autism often have lower levels of dopamine D2 receptors, a protein that helps regulate movement, learning, memory, reward and attention.

But following the probiotic treatment, researchers observed a burst in levels that suggested the cells were recovering.

Several brain pathways related to behavior, synapse organization and inflammation also improved.

The team looked a genes that were rescued by the treatment, finding a large amount occurred in astrocytes that regulate things like neurotransmitters and metabolism.

While excitatory neurons held the largest proportion of recovery. These are involved in the transmission of signals in the brain.

The researchers said the findings show that Lactobacillus murinus ‘[improves ASD-related social behavior deficits through bacteria-gut-brain communication.’

‘Our findings align with and extend previous research, which has shown that Lactobacillus murinu rescues behavioral deficits.’

Diet drug boom weighs heavily on state budgets

Colorado’s spending on highly effective but costly weight-loss drugs for state workers more than quadrupled from 2023 to 2024 — and costs have been doubling every six months.

Now, the state wants to scrap the benefit, arguing that it’s financially unsustainable.

But the potential removal of the popular benefit has sparked blowback among state workers. The state employees’ union argues ending coverage will cost the health plan in other ways — increasing spending on obesity-related diseases and leading to a less healthy workforce.

“[State employees] are very upset about this,” said Hilary Glasgow, executive director of the union, Colorado WINS. “Long-term obesity drives a lot of the major fatal diseases in America, and the employees I’ve talked to feel like they’re losing a lifeline that got thrown to them.”

The Colorado case underscores the broader struggle of states — many of which are facing budget shortfalls this year — that cover weight-loss drugs like Ozempic and Wegovy for state workers. Over the past three years, a growing number of states have taken leaps of faith in covering the expensive class of drugs, hoping that the benefit would lead to healthier workforces that would be less expensive to insure.

But with the number of prescriptions skyrocketing past projections — more than 1 in 10 Americans reported taking a GLP-1 drug, according to a May 2024 KFF Health Tracking poll — some states are limiting or ending the benefit.

At least two others — North Carolina and West Virginia — have already eliminated coverage due to cost concerns. That means state employees seeking the drugs for weight loss in those states will have to pay up to $1,500 a month for the treatments.

The issue is forcing states into difficult deliberations: Keep covering the drugs and risk depleting their budgets — and potentially increase premiums for everyone on their plans — or eliminate a benefit that many employees now rely on.

The dilemma also comes as states face their toughest budgetary pressures in years, in large part because federal cash they received during the pandemic has disappeared. And the Trump administration’s aggressive efforts to slash federal funding threatens to create further fiscal duress for states.

In a Fox News interview that aired Sunday, President Donald Trump lambasted the high price of the drugs.

“In London you get it for $88. In New York you get it for $1,200,” he said. “It’s very unfair.”

And if Trump follows through on his threat to impose tariffs on Denmark, the move could further drive up the costs of Ozempic and Wegovy, which are manufactured by Danish drugmaker Novo Nordisk — and create even greater fiscal challenges for state policymakers.

“The problem is the near-term cost is so high, and the benefits that you would gain are over a longer-term period,” said Charles Sallee, director of the New Mexico Legislative Finance Committee, which is exploring options to reduce the costs of covering the drugs for state employees. “But is that person still going to be in your health plan five years from now?”

Balancing costs and benefits

Because states can choose whether to cover GLP-1 drugs for weight loss, there is a patchwork of coverage for state employees across the country. At least 17 state employee health plans — an almost even mix of red and blue states — cover the drugs for weight loss, according to the Leverage Obesity Coverage Nexus.

The potential market for the drugs is massive — more than 40 percent of adults in the U.S. are obese — and has seen explosive growth. The number of Americans taking GLP-1s for weight loss rose more than 700 percent between 2019 and 2023, according to a recent study.

North Carolina opted to end coverage of the drugs for weight loss last year after estimating that the costs over the next six years could reach more than $1 billion. And West Virginia last year abruptly ended a subsidy program that helped state employees pay for the weight-loss drugs, saying the treatments were too expensive. Both states still cover the drugs for other conditions, like diabetes and cardiovascular disease.

Delaware started covering GLP-1s for weight loss for state employees in 2023, expecting to spend $1.8 million that year. The state ended up spending $14.2 million. For 2025, the plan expects to spend $52.8 million on weight-loss drugs.

The plan raised premiums 27 percent for fiscal year 2025 to address rising costs of prescription drugs and increased health care expenses overall. The state committee that manages the health plan has had discussions about limiting, or potentially ending, coverage. But adding restrictions raises another risk: Drugmakers might threaten to pull back tens of millions of dollars in rebates that plans receive for offering coverage.

“Once you’ve done it, it is difficult to take it away,” said Shaun O’Brien, a member of the Delaware State Employee Benefits Committee and the policy director of the American Federation of State, County, and Municipal Employees.

The health plan for New Mexico’s nearly 60,000 state and local government workers is projecting a $85 million budget shortfall in fiscal year 2025, according to a presentation from the state Health Care Authority obtained by POLITICO. The agency, which runs the plan, estimates GLP-1 costs for weight loss alone may exceed $20 million in 2025.

The Health Care Authority is projecting a $87 million budget shortfall and a more than 10 percent increase in drug spending in fiscal year 2026, largely driven by GLP-1 costs, according to the presentation. That means the plan would need a 29 percent premium increase in 2026 to cover the rising costs of medical and prescription drug claims.

New Mexico is struggling to contain the costs without ending coverage, said Sallee, the director of the Legislative Finance Committee. The panel is working with the Health Care Authority on options — including more restrictions on who can access the drugs, like a higher BMI threshold.

“Taking away what is widely seen as a highly effective drug at helping people lead healthier lives purely based on cost of a drug could be challenging,” said Sallee. “We should be working on getting better prices for the drugs.”

The committee has also floated purchasing compounded versions of the drugs, which can be cheaper than brand-name versions sold by drugmakers like Novo Nordisk and Eli Lilly. Compounded drugs contain the same basic ingredients as the brand-name versions, but the FDA doesn’t review them for safety and efficacy, posing risks for states looking to purchase them directly.

Colorado’s state employee union is trying to get Democratic Gov. Jared Polis to keep coverage of the drugs, which his administration proposed scrapping in its latest budget request. The state is facing a $1 billion budget shortfall, and the threat of suspension of some federal funding is compounding the financial challenges. Colorado WINS and the governor’s office are weighing how to continue covering the drugs against how much premiums might increase for everyone on the plan due to rising costs.

“To eliminate GLP-1s is short-sighted because of the cost of life-saving drugs later on for things like heart disease, cancer — the myriad of diseases that are driven by obesity or have obesity as a factor,” said Glasgow, the union executive director.

“Going in the wrong direction”

Connecticut’s state employee health plan last year took an experimental approach to coverage — requiring employees to enroll in a lifestyle management program called Flyte before receiving the medications. The program offers tools for weight management and personalized care plans. The state hoped adding the requirement would reverse the drugs’ cost trend, which was projected to reach $30 million in 2023.

The program showed early success in reducing the number of GLP-1 prescriptions, cutting the cost trend in half. The experiment also offered a potential road map for other organizations working through how to afford the drugs.

And clinically, the program has been a success: Enrollees have had a 16 percent drop in weight and BMI and a 14 percent drop in blood pressure. The outcomes have led to a happier and more productive workforce, said Connecticut State Comptroller Sean Scanlon.

But 19 months in, more and more state employees are enrolling in the program. Between October and January, more than 3,500 state employees joined Flyte, bringing the total to nearly 12,000 members. And while the program initially slashed the state’s $30 million cost for the drugs in half, those costs are creeping back up. The state now projects it will spend $23 million on the treatments in fiscal year 2025.

“Our cost trend is kind of now going back in the wrong direction,” said Scanlon. “But at the end of the day, I still believe that this is the right policy.”

Electrified Purification Could Eliminate Problematic Buffers

The buffers used in downstream purification play a critical role in drug manufacturing. However, they can be expensive and difficult to manage. Now, a novel approach called “electrified purification”—developed by Nyctea Technologies—offers an alternative.

Electrified purification is based on a conductive polymer that changes in response to electric signals. These changes can help control chromatography more effectively than buffer-based approaches, says Nyctea CEO and founder, Gustav Ferrand-Drake del Castillo.

“Think of it as a polymer coating that instantly goes from being sticky to anti-fouling by electric impulse,” he tells GEN.

“The advantages are that you can run this purification entirely in a neutral pH buffer of your choice and remove problematic elution buffers. For instance, imagine replacing low pH buffers used in the purification of mAbs in protein A, or imidazole used to purify His-tagged proteins.”

Nyctea claims the approach significantly increases yields—the firm’s current record is a 600% bump compared with commercial chromatography systems.

The use of electrical impulses also speeds up the purification process, Ferrand-Drake del Castillo says, explaining that “instant millisecond switches reduce the cycle time and use of raw materials by replacing elution chemicals and reducing water use by up to 60%.”

He adds, “Our coating is compatible with Protein A, meaning we can attach ligands to make the coating ultra-specific. We are also working on a version of the product that is ligand-free, meaning highly efficient ion-exchange with extremely high specificity without requiring an affinity ligand. This is still early in development, but we are convinced we can get there.”

Partnerships

Nyctea, a spinout from Gothenburg’s privately-owned Chalmers University of Technology, was founded in 2020 to commercialize electrified purification. At present, the focus is on finding ways to use it at scale.

Ferrand-Drake del Castillo says: “The material science behind Nyctea purification was invented four years ago and we are still early in a rapid learning curve.

“This means we have not yet developed large-scale off-the-shelf products, and still need to validate many industrial use-cases to build the necessary data for industry-wide adoption of the technology. However, we already have use cases where we exceed existing commercial products in performance, which is exciting considering that our product is still in its infancy,” he adds.

And the technology has already attracted biopharmaceutical industry interest. In January, Nyctea partnered with AstraZeneca to see if electrified purification could improve the Anglo-Swedish drug maker’s production processes.

“The collaboration focuses on improving the purification of next-generation advanced medicinal therapies. Our product is still at a developmental stage, meaning that the product is currently only suitable for research and process development. The strategy is to advance our products toward commercial biomedicine production as quickly as possible to impact production costs and, thereby, provide patient accessibility to the next generation of biologics,” says Ferrand-Drake del Castillo. “We have other undisclosed industrial customers. We have ongoing conversations with multiple other drug companies to initiate partnerships.”

Antibiotic Resistance Linked to Extra Pump Proteins in Gram-Negative Bacteria

Scientists from Cornell University, University of California, San Francisco (UCSF), and elsewhere have found that a surplus of membrane proteins may help bacteria survive antibiotic exposure. These proteins are part of a shuttling mechanism that bacteria use to pump out a wide spectrum of antibiotics along with other physiological substrates from the cell. The researchers are now focused on using chemical and mechanical manipulations to disrupt the process so that antibiotics can be more effective.

Details of the study were published in Cell Reports Physical Science in a paper titled, “Transporter excess and clustering facilitate adaptor-protein shuttling for bacterial efflux.”

In it, the researchers describe how an imbalance in the three-part protein complex—MacAB-TolC—helps gram-negative bacteria resist antibiotics. The MacAB-TolC complex, known as a multidrug efflux pump, spans the cell’s inner and outer membranes, as well as the periplasm that connects them. Each protein occupies a different location: TolC on the outer membrane, MacB on the inner membrane, and MacA in the periplasm, although it is anchored on the inner membrane. This protein complex forms a conduit that drains out antibiotics as well as virulence factors produced by the bacterial cell.

The three proteins need to assemble in a specific stoichiometry to pump out toxins. Two MacB proteins assemble with six MacA proteins, then three TolC proteins. Scientists understand this ratio well. What’s not been clear is how molecules in the periplasm enter the channel that runs through the complex and through which substrates they get pumped, once the structure is assembled.

To understand this process, the scientists used single-molecule imaging to analyze protein concentrations inside Escherichia coli (E. coli) cells. They found that the protein stoichiometry was imbalanced, with a surplus of MacBs floating around and even more TolC. The quantities were far more than were necessary for the complex’s 2:6:3 configuration. In addition, researchers noticed the adaptor protein MacA could disassemble from the MacAB-TolC assembly.

 

“You basically have these extra Bs that don’t have A partners to assemble. And of course, the cell does not do this for no reason,” said Peng Chen, PhD, study lead and a professor of chemistry at Cornell University. “We found out a good reason is that when you have this extra B, because it does not have A associated with it, it naturally has an opening for the substrate to go in. So once the substrate can bind to the extra B, some of the As that are initially associated with B can migrate over to assemble. And once it’s assembled, they can pump the substrate out.”

As part of the study, the researchers tested whether the mechanism could be interrupted. They used a microfluidic device developed at UCSF that applies mechanical stress to change bacteria’s toxin resistance. They found that squeezing E. coli through the device deformed the cell enough to disrupt the assembled complex and prevent it from resisting antibiotics.

The scientists believe that the behavior observed in E. coli likely exists in other systems. “This imbalance of protein stoichiometry must exist for many types of protein complexes. But how does a cell utilize this imbalance?” Chen said. “Now we have one example that shows this particular imbalance might be, functionally, very relevant. So anytime that we study protein complexes in the cell, we always want to measure the relative amount in the entire cell versus their relative amount in a particular complex. Do they actually match?”

Immune System Regulated by Fluoxetine to Fight Infections and Sepsis in Mice

Selective serotonin reuptake inhibitor (SSRI) antidepressants are some of the most widely prescribed drugs in the world, and new research suggests they could also protect against serious infections and life-threatening sepsis. Scientists at the Salk Institute studying a mouse model of sepsis uncovered how the SSRI fluoxetine can regulate the immune system and defend against infectious disease, and found that this protection is independent to peripheral serotonin. The findings could encourage additional research into the potential therapeutic uses of SSRIs during infection.

“When treating an infection, the optimal treatment strategy would be one that kills the bacteria or virus while also protecting our tissues and organs,” commented professor Janelle Ayres, PhD, holder of the Salk Institute Legacy Chair and Howard Hughes Medical Institute Investigator. “Most medications we have in our toolbox kill pathogens, but we were thrilled to find that fluoxetine can protect tissues and organs, too. It’s essentially playing offense and defense, which is ideal, and especially exciting to see in a drug that we already know is safe to use in humans.”

Ayres is senior author of the team’s report in Science Advances. In their paper, titled “Fluoxetine promotes IL-10–dependent metabolic defenses to protect from sepsis-induced lethality,” the investigators stated, “Our work reveals a beneficial ‘off-target’ effect of fluoxetine, and reveals a protective immunometabolic defense mechanism with therapeutic potential.”

Selective serotonin reuptake inhibitor antidepressants are prescribed for their ability to increase serotonergic signaling in the brain, but they are also known to have a broad range of effects beyond the brain, including immune and metabolic effects, the authors wrote. “It is now recognized that SSRIs also have a wide range of peripheral effects including regulation of immune and metabolic processes.”

Prior research has also found that users of SSRIs such as fluoxetine had less severe COVID-19 infections and were less likely to develop long COVID. Another study found that fluoxetine was effective in protecting mice against sepsis, a life-threatening condition in which the body’s immune system overreacts to an infection and can cause multi-organ failure or even death.

“… SSRIs have been shown to protect against sepsis in animal models and improve outcomes in patients infected with severe acute respiratory syndrome coronavirus 2,” the investigators stated. However, they pointed out that the mechanisms underlying these protective effects have remained unclear.

While our immune systems do their best to protect us against infections, sometimes they can overreact. In sepsis, the inflammatory response spins so out of control that it starts damaging a person’s own tissues and organs to the point of failure. “Sepsis is defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection,” the authors further commented. “Sepsis is largely driven by an overexuberant inflammatory response to an infection.” This same overreaction is also characteristic of severe COVID-19 illness.

One solution might be to suppress the inflammatory response, but doing so can actually make patients more vulnerable to their initial infection and more susceptible to new infections. Timing is also critical, as immunosuppressive drugs need to be administered before any tissue damage has taken place. And while numerous clinical trials have been performed with neutralizing antibodies that target pro-inflammatory cytokines, the team pointed out, “… these approaches have been met with little success.”

Instead, an ideal treatment would proactively control the intensity and duration of the immune response to prevent any bodily damage and also kill the infection that puts the body at risk to begin with. “Host-directed therapeutics that can control the degree and duration of an immune response to allow pathogen killing but prevent the escalation of the response to a cytokine storm and that also promote metabolic adaptation to the infected state may offer more therapeutic benefit than strategies that focus only on blocking the pro-inflammatory response,” they suggested.

To understand what SSRIs might be doing in this context, Ayres and colleagues studied mice with bacterial infections and separated them into two groups, one pretreated with fluoxetine and the other not given fluoxetine pretreatment. The results demonstrated that mice pretreated with fluoxetine were protected from sepsis, multi-organ damage, and death.

To better understand the findings the team carried out a number of investigations. They first measured the number of bacteria in each mouse population eight hours after infection. They found that mice treated with fluoxetine had fewer bacteria at this stage, signifying a less severe infection, and indicating that fluoxetine had antimicrobial properties that allowed it to limit bacterial growth.

Next, the researchers measured the levels of different inflammatory molecules in each group. They saw more anti-inflammatory IL-10 in their pretreated populations and deduced that IL-10 prevented sepsis-induced hypertriglyceridemia—a condition in which the blood contains too many fatty triglycerides. This enabled the heart to maintain the proper metabolic state, protecting the mice from infection-induced morbidity and mortality.

The team also decoupled this IL-10-dependent protection from multi-organ damage and death from their earlier discovery of fluoxetine’s antimicrobial effects, in turn revealing the drug’s dual-purpose potential to kill pathogens and alleviate infection-induced damage to the body.

To understand how fluoxetine’s influence on serotonin levels might be contributing to these effects, the researchers also looked at two new mouse populations. Both were pretreated with fluoxetine, but one had circulating serotonin, while the other did not. Circulating serotonin is a chemical messenger that travels the brain and body, and is involved in regulating mood, sleep, and pain. Ayres and colleagues found that fluoxetine’s positive health outcomes were entirely unrelated to circulating serotonin. Regardless of whether the mice had serotonin in circulation, they experienced the same infection defense benefits from fluoxetine. “We found that fluoxetine pretreatment promotes both resistance and cooperative defenses in a peripheral serotonin-independent manner,” they wrote.

“That was really unexpected, but also really exciting,” commented study first author Robert Gallant, PhD, a former graduate student researcher in Ayres’ lab. “Knowing fluoxetine can regulate the immune response, protect the body from infection, and have an antimicrobial effect—all entirely independent from circulating serotonin—is a huge step toward developing new solutions for life-threatening infections and illnesses. It also really goes to show how much more there is to learn about SSRIs.”

Ayres and Gallant say their next step is to explore fluoxetine dosing regimens appropriate for septic individuals. They’re also eager to see whether other SSRIs can have the same effects.

“Fluoxetine, one of the most prescribed drugs in the United States, is promoting cooperation between host and pathogen to defend against infection-induced disease and mortality,” said Ayres, who is also the head of Molecular and Systems Physiology Laboratories at Salk. “Finding dual protective and defensive effects in a repurposed drug is really exciting.”
In conclusion, the authors wrote, “Our study mechanistically links the anti-inflammatory and metabolic effects of an SSRI and demonstrates that fluoxetine can be used as a prophylactic to protect from sepsis-induced lethality by orchestrating protective immunometabolic mechanisms, which may be leveraged and further explored by future studies.”

Guanylhydrazone-Based Small Molecule Discovered That Mimics bFGF for Cell Culture Applications

The Cultivated B, a Heidelberg, Germany-based company, reports the discovery of a chemical class of FGFR1 agonists mimicking basic fibroblast growth factor’s (bFGF) effect on cell proliferation, an essential component of cell-culture media. A preprint of the study is published on bioRxiv.

“This class of small molecules offers a stable, highly cost-effective alternative, poised to transform cultivated meat, biopharmaceuticals, regenerative medicine, and large-scale cell manufacturing by addressing key challenges,” said Hamid Noori, PhD, CEO and founder of The Cultivated B and a Forbes Councils member.

The discovery revolutionizes cell production by overcoming key bottlenecks such as rapid degradation, high production costs, batch variability, and complex storage requirements, according to Noori, who added that, unlike traditional bFGF, small molecules remain active for over 13 days, thus providing where stability, consistency, and scalability.

“We are unlocking new possibilities for entire industries,” he continued. “This breakthrough has the potential to revolutionize the scalability, consistency, and cost-effectiveness of cell-based product manufacturing, including applications in cultivated meat and cell therapy.”

The Cultivated B was founded in 2009 and develops technologies involved in cellular agriculture, precision fermentation, and bioreactor engineering. The German Institute for Innovation in Sustainability and Digitalization named The Cultivated B the “2024 Employer of the Future.”

Ozempic shown to reduce drinking in first trial in alcohol-use disorder

For years, people taking Ozempic or other drugs in the same class for diabetes and weight loss have noticed the medicines don’t just curb their desire to eat; for some, they also lead them to drink less alcohol.

Now, the first clinical trial – although relatively small and limited in duration – has confirmed it.

A study of 48 people with signs of moderate alcohol-use disorder found that those taking low doses of semaglutide – the generic name of Ozempic – for nine weeks saw significantly greater reductions in how much alcohol they drank, as well as cravings for alcohol, compared with people on a placebo. The results were published Wednesday in the journal JAMA Psychiatry.

The findings underscore what multiple analyses of real-world use of the so-called GLP-1 medicines, as well as studies in animals, had already hinted at: Ozempic and similar drugs, already incredibly popular, could help reduce risks of overconsuming alcohol, if the results bear out in larger and longer trials.

“We hoped to see a reduction in drinking and craving,” said Dr. Christian Hendershot, director of clinical research at the USC Institute for Addiction Science and the lead author of the study. “What I didn’t expect was the magnitude of the effects looks fairly good … compared to other alcohol-use disorder medications.”

Alcohol-use disorder, or AUD, affects almost 30 million people in the United States, according to the 2023 National Survey on Drug Use and Health, and it’s characterized by having trouble stopping or controlling alcohol use despite negative consequences from it.

And increasingly, health guidance points to consuming less alcohol or abstaining to improve health; last month, former US Surgeon General Dr. Vivek Murthy issued an advisory warning that alcohol raises the risk of at least seven types of cancer, and called for updated health warning labels on alcoholic beverages.

Whether Ozempic and other similar drugs present a new way of treating AUD will depend on larger trials in patients more heavily afflicted by the disorder, experts said, and potentially whether research can yield a better understanding of how the medicines work to reduce drinking.

There are three medicines approved by the US Food and Drug Administration for AUD, but fewer than 2% of people with the disorder receive treatment with them, Hendershot and his co-authors wrote in their paper, noting few people may know about them and that stigma may pose a barrier to treatment.

One of the medicines, naltrexone, has shown a small effect size on alcohol-use disorder, Hendershot told CNN. The semaglutide trial showed effect sizes “in the medium to large range,” he said, although he urged caution about the results since the trial “was the first to look at this question in a controlled way.”

Semaglutide, sold by Novo Nordisk as Ozempic for type 2 diabetes and Wegovy for obesity, is part of a class of drugs known as GLP-1 receptor agonists, mimicking the hormone GLP-1 to reduce appetite, slow stomach emptying and regulate insulin. Eli Lilly sells the other major drugs in the class, Mounjaro for diabetes and Zepbound for obesity, based on the active ingredient tirzepatide. In addition to GLP-1, they also mimic another hormone called GIP.

The drugs work in both the gut and the brain – which may be the way they could help with AUD, said Dr. Lorenzo Leggio, a physician-scientist at the National Institutes of Health who wasn’t involved in this study.

“More research is needed to understand the mechanism(s) of action of these medications in AUD,” Leggio, who’s published research on semaglutide’s ability to reduce alcohol drinking in animals, wrote in an email to CNN. “Nonetheless, the work done now suggests that mechanisms may include their effect in reducing alcohol craving and in reducing the rewarding effects of alcohol.”

A bar in a lab

The study, funded by the National Institute on Alcohol Abuse and Alcoholism and conducted at the University of North Carolina-Chapel Hill School of Medicine, enrolled people with alcohol-use disorder who weren’t seeking treatment. They reported drinking more than seven drinks in a week, if they were women, or 14 if they were men, within the last month, with two or more heavy drinking episodes, defined as at least four drinks at a time for women or five for men.

Half received low-dose injections of semaglutide each week and half received a placebo shot. They came in weekly for visits.

Their first was a bit unusual for a clinical trial, although not for one studying alcohol: participants spent two hours in a lab made to feel like a living room, complete with National Geographic episodes playing on TV – and a bar stocked with their favorite alcoholic drink.

“They were free to drink as much as they wanted to, up to a limit we set” for safety, Hendershot said. Someone from the study would come in every half an hour to take breath alcohol measurements and administer some questionnaires.

They did it again at the end of the nine weeks of treatment. Then the researchers compared the results.

When participants returned to the living room lab at the end of the study, those taking semaglutide drank about 40% less alcohol than those on placebo, the study found. In additional measures in the study, participants on the medicine also drank fewer drinks per day overall and had fewer heavy drinking days, as well as reduced cravings for alcohol.

“It’s one of the first trials that’s a randomized, controlled trial that have said, ‘You know what, there is evidence that people will drink less if they’re taking this medicine,’” Dr. Daniel Drucker, a professor of medicine at the University of Toronto who pioneered research on GLP-1, told CNN.

Drucker noted, though, he’d like to see more detailed information about the side effects individual participants experienced, and whether they had any correlation with how much alcohol they drank.

“If you have persistent low-grade nausea and you’re not feeling well, well of course you wouldn’t drink as much,” Drucker said – although he noted this is not the main reason people lose weight on the medicines, as the side effects usually are worst when people begin treatment and when they increase their doses.

The most common side effects of GLP-1 medicines are nausea, constipation and other gastrointestinal issues, and participants on semaglutide in the trial experienced generally mild effects of that nature as well, the researchers said.

Hendershot said the size of the study meant they didn’t feel they had enough data to measure the correlation of side effects with drinking, but said that since side effects are generally a bigger issue at the beginning of treatment and during dosage increases, “we don’t think that GI side effects can fully account for the findings.” In the study, the effects on drinking were generally largest at the end. Hendershot said it’s something to study more definitively in the future.

Where Ozempic didn’t work

The trial found that semaglutide didn’t appear to affect how many days out of the week people chose to drink alcohol – just that when they drank, they drank less. And that may be a helpful goal for people seeking treatment for AUD, said Dr. Raymond Anton, an addiction psychiatrist and emeritus professor at the Medical University of South Carolina.

“The field in general has been pushing for a reduction goal in clinical trials and the FDA is moving in that direction,” Anton told CNN by email. “Most people seeking treatment do not want a goal of abstinence for the rest of their lives.”

Anton also said he’d like to see data on whether side effects like nausea and fatigue had an effect on alcohol drinking, and also whether there was a correlation between weight loss and drinking reduction. In the study, participants on semaglutide lost about 5% of their body weight over nine weeks.

He also noted the people in the study were different from those who typically seek treatment for AUD; it had a lot more women than men – atypical of most AUD trials, he said – and they were of higher than normal weight, which he said also isn’t typical of the average person seeking treatment for AUD. And, Anton said, those seeking treatment generally drink more than people in this trial reported – seven to eight drinks per day, and often much more, on the majority of days.

There are already more trials underway to better understand the promise of GLP-1 drugs in AUD, including one at the NIH. But to obtain FDA approval for the disorder, pharmaceutical companies likely need to get involved.

Novo Nordisk and Eli Lilly have been slower to pursue addiction indications for the medicines, while running trials proving their cardiovascular benefits, effects on kidney disease, heart failure and sleep apnea. Novo Nordisk is even evaluating semaglutide for Alzheimer’s disease, with results expected late this year.

But last year, the Danish drug giant said it would look at semaglutide’s effects on alcohol consumption as part of a trial in alcohol-related liver disease. And Lilly’s CEO told an audience at an event in December that the company planned to start large studies in alcohol abuse, nicotine use and drug abuse this year.

Key questions remain, including how the drugs should be used in people who don’t have excess weight. In Hendershot’s study, anyone with a body mass index, or BMI, of at least 23 could enroll, which would include people considered to have a healthy body weight; the medicines are approved by the FDA for people with a BMI of 30, indicating obesity, or of at least 27 – overweight – and a weight-related health condition. Only one person in the trial started with a BMI of less than 24.9, the researchers said.

And there’s still more data to come. Hendershot and his team also assessed cigarette use among a subsection of participants who smoked. Though the sample size was small – just 13 of the 48 participants reported smoking cigarettes – the study found those on semaglutide tended to smoke fewer cigarettes per day, mirroring anecdotes from patients prescribed the drugs for weight loss.

“Should GLP-1 receptor agonists prove efficacious for both alcohol reduction and smoking cessation,” the researchers concluded, “potential health implications could be substantial.”

FDA approves new genetic disorder drug

The Food and Drug Administration (FDA) approved a new drug to treat a disorder causing the growth of noncancerous tumors on nerves throughout the body.

The federal agency said on Tuesday it greenlighted SpringWorks Therapeutics’s drug Gomekli for patients dealing with neurofibromatosis type 1 (NF1) “who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection.”

The drug was approved after a multicenter, single-arm trial of 114 patients — 58 adults — with “symptomatic, inoperable NF1-associated PN causing significant morbidity,” according to the FDA.

Gomekli showcased at least a 20 percent reduction in the volume of the tumor in more than 50 percent of pediatric patients and 41 percent of adult patients, Reuters noted.

“The NF1-PN patient community has a great need for more treatment options. With today’s approval, we are honored to serve both adults and children with NF1-PN and provide them with a therapy that has the potential to shrink their tumors and offer meaningful symptomatic relief,” SpringWorks CEO Saqib Islam said in a statement on Tuesday.

“We are grateful to each clinical trial participant, their families, the investigators, and the patient advocacy groups involved in the journey towards making GOMEKLI available in the U.S.,” Islam added. “I am proud that we are delivering on our commitment to patients with devastating diseases with our company’s second FDA approval in less than 18 months.”

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