FDA Approves Expanded Pharmacy Distribution for Qsymia

Vivus will be carefully expanding the distribution for their newly launched obesity treatment, Qsymia, with approval from the FDA. Until now, Qsymia was sold through a tightly controlled distribution system of mail order pharmacies. While that system may have been effective to assure safe use early in the drug’s introduction, it also created hardships for both prescribers and patients who needed the product for the treatment of obesity.

Within 90 days, Qsymia will be available in thousands of pharmacies certified to follow the terms of the Risk Evaluation and Mitigation Strategy (REMS) approved and now modified by FDA.

“With FDA approval of the REMS modification, today we begin the process of increasing the availability of Qsymia, simplifying prescribing and dispensing and resolving the challenges associated with the mail-order-only system,” said Peter Tam, president of Vivus.

“The addition of certified retail pharmacies to the Qsymia network will reduce the prescribing burden for physicians and the waiting times for patients seeking to initiate therapy for obesity,” said Barbara Troupin, MD, vice president, scientific communication and risk management at Vivus. “While the Qsymia certified mail-order pharmacies will remain, the addition of retail availability will improve the overall physician and patient experience.”

Vivus is walking a careful line here. They have succeeded in being first to market with the first new treatment for obesity in more than a decade. Obesity is a serious chronic condition with great unmet medical need. But ample case history shows that obesity treatments can run into trouble with misuse and the safety problems that ensue. Investors are impatient and analysts wonder if careful marketing by Vivus can overcome all of the barriers to success in the obesity market. Still the company seems to be following a prudent course of delivering on carefully managed expectations.

Click here to read more from The Motley Fool, click here to read more from the Wall Street Journal, and click here for the Vivus press release.

The Abbey Pharmacy, image © Sarah Smith / Wikimedia

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