Obesity specialists warn against ‘bootleg’ weight-loss drug

Semaglutide, a weight loss drug developed by Novo Nordiskis currently in short supply due to high demand, which leads some people to look for “generic” or composite versions of the drug, Sophie Putka reports for MedPage Today. But obesity specialists warn against the use of compound semaglutide as its quality and safety can not be guaranteed.

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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.

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To evaluate its potential use as a treatment for obesity, 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 more than 4,500 participants.

Across all four STEP clinical trials, participants receiving semaglutide lost, on average, between 10% and 17% of their body weight. In general, the drug performed much better than other anti-obesity drugs, which typically resulted 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 since 2014 for such use.

According to Robert Kushner, an obesity researcher at North-West University Feinberg School of Medicine, which led one of the STEP studies, semaglutide is a “game-changer” for people with obesity. “This is the beginning 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 compound 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 lose pounds at a consistent rate.” Just like that, Cru Clinican aesthetic medical center, says it offers compound semaglutide as an alternative to the more expensive Novo Nordisk remedy.

According to the Alliance for Pharmacy Compositioncomposite pharmacies, which have less stringent regulations, can use semaglutide in composite products because it is not a “biological” and is a component of an FDA-approved product.

Separately, an FDA spokesman Center for Drug Evaluation and Researchsaid it is possible that compound semaglutide is exempt from normal FDA approval if it is “made using a bulk drug (active ingredient) that is a component of an FDA-approved human drug product, subject to all other conditions. .. be complied with. “

However, Novo Nordisk holds several patents that protect its semaglutide-using medication, including the diabetes drug Ozempic, and said that organizations that sell semaglutide products “may be violating Novo Nordisk’s intellectual property rights and / or violating applicable law.” The company added that it would “take such steps as it deems necessary and appropriate to protect its intellectual property rights.”

“Nobody knows how [compounding pharmacies are] get it, “said Karl Nadolsky, an endocrinologist at Spectrum Health. “Who makes it? Novo does not give it to them. They are the ones with the rights to the molecule, so how does anyone get semaglutide?”

Doctors remain skeptical about compound reformulations

Even as interest in compound semaglutide increases, endocrinologists and obesity medicine remain skeptical about the reformulated drug, comparing it to a “bootleg” version of the original where safety and quality cannot be guaranteed.

According to Ricardo Correa, the Endocrinology Society director at the University of Arizona College of Medicinecompound pharmacies “probably use the same active pharmacological component [semaglutide]but when you combine things and you add different excipients, the effectiveness – if you do not measure it in a randomized controlled trial – will not be the same. ”

“I can tell you, the consensus among legal practicing obesity endocrinology specialists is to avoid it because it’s just too much unknown,” Nadolsky said.

So far, many endocrinologists and obesity specialists have said that they will not prescribe compound semaglutide for their patients as they may not 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 Hospitalsaid: “My assumption would be that they make an agent nearby,” but that “I can see no chance 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 compound semaglutide or another similar drug. “[I]”If I myself would not be comfortable receiving it, I would not have to prescribe it to anyone else,” she said.

“I understand we are frustrated because we can not get the GLP-1s. [glucagon-like peptide-1 receptor agonists, the drug class semaglutide falls into]but just because these are desperate times does not mean we are using desperate measures, ”Stanford added.

In addition, providers prescribing compound semaglutide may be at risk of harming their patients, as well as their careers, if a patient eventually becomes ill.

“You treat 100 patients and all of them did well with a compound medication you recommend. One develops a problem,” Correa said, describing a hypothetical situation. “That’s it. This is the end of your career.” (Putka, MedPage Today7/7)

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