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July 12, 2022

Obesity specialists warn against 'bootleg' weight-loss drug

Daily Briefing

    Semaglutide, a weight-loss drug developed by Novo Nordisk, is currently in short supply due to high demand, leading some people to seek out "generic" or compounded versions of the drug instead, Sophie Putka reports for MedPage Today. But obesity specialists warn against using compounded semaglutide since its quality and safety cannot be guaranteed.

    Webinar: Obesity and diabetes market trends for 2022

    What is semaglutide?

    Semaglutide is a drug that mimics a hormone called glucagon-like peptide-1 to target areas of the brain that regulate appetite and food intake. It has also been used as a treatment for type 2 diabetes.

    To assess its potential use as an anti-obesity treatment, Novo Nordisk funded the Semaglutide Treatment Effect in People with Obesity (STEP) clinical trial program. The STEP program included four phase 3 clinical trials with over 4,500 participants.

    Across all four STEP clinical trials, participants who received semaglutide lost an average of between 10% and 17% of their body weight. Overall, the drug performed much better than other anti-obesity medications that typically result in a 5% to 9% reduction in body weight.

    In June 2021, FDA approved semaglutide as a treatment for chronic weight management in obese or overweight adults—the first drug approved for such use since 2014.

    According to Robert Kushner, an obesity researcher at Northwestern University Feinberg School of Medicine, who led one of the STEP studies, semaglutide is a "game-changer" for people with obesity. "This is a start of a new era of effective treatments for obesity," he added.

    High demand leads companies to offer 'generic' semaglutide

    Currently, semaglutide, also known as Wegovy, is in short supply due to "unprecedented demand" after its approval. This has led some companies to offer "generic" or compounded formulations of the drug.

    For example, the Compounding Pharmacy of America offers "combined high-quality semaglutide with L-carnitine, a fat-mobilizing amino acid," which "creates a powerful symbiosis of weight loss mechanisms that help you shed pounds at a consistent rate." Similarly, Cru Clinic, an aesthetic medical center, says it offers compounded semaglutide as an alternative to the more expensive Novo Nordisk drug.

    According to the Alliance for Pharmacy Compounding, compounding pharmacies, which have less stringent regulations, may be able to use semaglutide in compounded products because it is not a "biologic" and is a component of an FDA-approved product.

    Separately, a spokesperson for FDA's Center for Drug Evaluation and Research, said it was possible compounded semaglutide is exempt from normal FDA approval if it is "made using a bulk drug substance (active ingredient) that is a component of an FDA-approved human drug product, provided all other conditions ... are met."

    However, Novo Nordisk owns multiple patents protecting its medications that use semaglutide, including the diabetes drug Ozempic, and said that organizations selling semaglutide products "may be infringing Novo Nordisk's intellectual property rights and/or violating applicable law." The company added that it "will take such actions as it deems necessary and appropriate to protect its intellectual property rights."

    "Nobody knows how [compounding pharmacies are] getting it," said Karl Nadolsky, an endocrinologist at Spectrum Health. "Who's making it? Novo's not giving it to them. They're the ones with the rights to the molecule, so how is anybody getting semaglutide?"

    Physicians remain skeptical of compounded reformulations

    Even as interest in compounded semaglutide grows, endocrinologists and obesity medicine specialists remain skeptical of the reformulated drug, likening to it to a "bootleg" version of the original where safety and quality cannot be ensured.

    According to Ricardo Correa, the endocrinology fellowship director at the University of Arizona College of Medicine, compound pharmacies "are probably using the same active pharmacological part [semaglutide], but when you combine things and you add different excipients, the effectiveness—if you don't measure that in a randomized controlled trial—will not be the same."

    "I can tell you, the consensus amongst legitimate practicing obesity endocrinology specialists is to avoid this, because it's just too much unknown," Nadolsky said.

    So far, many endocrinologists and obesity specialists said they will not prescribe compounded semaglutide for their patients, since they cannot be sure what ingredients are in it or how it works compared to the original drug.

    Fatima Cody Stanford, an obesity specialist at Massachusetts General Hospital, said, "My assumption would be that they're making an agent that's close," but that "I can't chance anything with my patients. I need to see the data to support the use."

    For all her patients, she first asks herself if she would be comfortable receiving compounded semaglutide or another similar drug. "[I]f I wouldn't, myself, be comfortable receiving it, then I don't need to prescribe it for someone else," she said.

    "I understand we're frustrated because we can't get the GLP-1s [glucagon-like peptide-1 receptor agonists, the drug class semaglutide falls into], but just because it's desperate times doesn't mean we use desperate measures," Stanford added.

    In addition, providers who prescribe compounded semaglutide may risk harming their patients, as well as their careers, if a patient ends up getting sick.

    "You're treating 100 patients and all of them have been doing fine with a compound medication you recommend. One develops a problem," Correa said, describing a hypothetical situation. "That's it. That's the end of your career." (Putka, MedPage Today, 7/7)

    Diabetes and obesity market trends

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    webinarThe opportunity to provide care for obese and diabetic patients has existed over the last few decades, but the pandemic has placed an outsized spotlight on these diseases over the last two years. Watch this webinar to learn about the growing demand for obesity and diabetes services, a quick overview of disease prevalence and future market growth, and a look into some major trends affecting stakeholders from across the landscape.

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