Weight Loss Drug Market Faces New Challenges Amid Regulatory scrutiny
the Rise of Compounded Semaglutide
As U.S. pharmaceutical regulatory authorities increase their oversight of generic drug production, particularly for high-demand medications, online weight loss companies are adapting. Sharing, an online weight loss company, has announced it will offer a compounded version of semaglutide, the active ingredient in drugs like Wegovy and some diabetes medications. This offering is designed to comply with evolving regulations from the Food and Drug Administration (FDA).
Sharing’s Approach to Personalized Programs
Sharing plans to incorporate this compounded semaglutide into patients’ customized weight loss programs. This approach comes as demand for next-generation weight loss drugs has surged, driving sales for Sharing and its competitors in the remote medical space over the past two years.
Did You Know?
Semaglutide, the active ingredient in Wegovy, works by mimicking a hormone that targets areas of the brain to regulate appetite and food intake. This can lead to critically important weight loss when combined with diet and exercise.
The Microdosing Trend
The high cost and potential side effects of weight loss drugs have fueled the popularity of “microdosing,” where patients take smaller quantities of these medications. Patients have been accessing semaglutide or tirzepatide, manufactured by doctors or pharmacies, at prices lower than branded drugs. This access was previously facilitated by a regulatory exception related to drug shortages.
FDA Regulations and the End of the Shortage Exception
However, the FDA has declared that the drug shortage is over, and the sunset deadline for the exception that allowed compounded versions of these drugs was May 22. This change in regulatory status has significant implications for companies offering compounded versions of these medications.
Pricing and Market Dynamics
Sharing offers a semaglutide compound at a starting price of $149 per month. In comparison, the price of a 2.5-milligram dose of Wegovy or Mounjaro is approximately $349, according to novo Nordisk and Eli Lilly websites. Analysts suggest that weight loss companies may need to seek bankruptcy protection or transition to branded pharmaceuticals to remain viable.
Medical Rationale Behind Lower Doses
Jeffreeler, the chief medical officer of Sharing, explained the rationale behind offering lower doses: The medical staff will determine whether the patient needs less capacity as of concerns about camouflage side effects, or helps to increase compliance or to maintain weight loss.
Compliance with Regulations
Jeff Cook, CEO of Sharing, believes that their practices comply with regulations. There’s always an exception to personalized, and I’ve always been there,
Cook stated.
Novo Nordisk’s Stance
Novo Nordisk maintains that creating or selling semaglutide replicas in the United States is illegal, except under rare circumstances. As the FDA warned, as the FDA warned,
the company said in a statement.
Pro Tip:
Always consult with a healthcare professional before starting any weight loss medication. Discuss potential side effects, drug interactions, and the most appropriate dosage for your individual needs.
Dosage and Personalized Approaches
According to documents from NOOM, personalized approaches may involve gradually increasing the dosage to about half of the FDA’s maximum capacity of 2.4mg over 20 weeks, starting with half of the general start capacity of 0.25 milligrams. Sharing emphasizes that their approach is not solely based on the microdosing trend and that patients can increase their dosage to the target capacity, albeit at a slower pace.
Continued Availability of Branded Drugs
Sharing asserts that they will continue to sell not only Eli Lilly’s Zebound but also Novo Nordisk’s branded drugs.
Efficacy of Weight Loss Drugs
Clinical trials of Wegovy and Zebound have demonstrated that these drugs can reduce weight by 15-20%. Recent studies suggest that taking half of the usual dose of semaglutide can be as effective for weight loss as the current dose.
The Future of compounding
Compounding pharmacies can create personalized generic drugs that are not available in branded medicines. However, the FDA is evaluating whether tirzepatide and semaglutide belong to drug categories too complex for compounding, which could potentially end this practice. Even now, the compounds can technically make Semagluide and Tirze Partides personalized,
she says.
