Diet Pill Shares Rise
USA drugmaker Vivus’ (Nasdaq: VVUS) shares rose as much as 11% by traded up 5% at $11.69, after the company exposed on April 16 that the US Food and Drug Administration has accepted its alteration and adjustments to the Risk Evaluation and Mitigation Strategy (REMS) for its diet pill Qsymia (phentermine and topiramate extended-release) capsules CIV.
The modification, submitted in October 2012, allows Qsymia to be dispensed through certified retail pharmacies, in addition to the existing network of certified mail-order pharmacies. Vivus has blamed Qsymia's disappointing launch, in part, on the mail-order pharmacy restriction imposed with its July 2012 approval. Sales totaled $2 million in the fourth quarter, well below investor expectations.
“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. “Our goal over the next three months is to ensure availability of Qsymia in thousands of certified retail pharmacies nationwide. The REMS modification is a key accomplishment in removing a major barrier that has hindered the initial acceptance of Qsymia into everyday medical practice. We believe that retail access, along with ongoing improvements in reimbursement, will help to accelerate Qsymia awareness, trial and usage,” he added.
Will reduce prescribing burden
“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, vice president, scientific communication and risk management, at Vivus, noting that, “while the Qsymia certified mail-order pharmacies will remain, the addition of retail availability will improve the overall physician and patient experience.”
With this modification, the goals, commitments and components of the original Qsymia REMS will remain in place, including a Medication Guide, patient brochure,
voluntary health care provider training and other educational tools. These will continue to be available as part of the modified Qsymia REMS program. Availability at certified retail pharmacies is expected within 90 days, said Vivus.