The US Food and Drug Administration (FDA) has approved Vivus, Inc.'s amendment and modification to the Risk Evaluation and Mitigation Strategy (REMS) for Qsymia (phentermine and topiramate extended-release) capsules CIV. The amendment was submitted in October 2012, allows Qsymia to be dispensed through certified retail pharmacies, in addition to the existing network of certified mail-order pharmacies.

"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."

"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, Vivus. "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 healthcare provider training and other educational tools. These will continue to be available as part of the modified Qsymia REMS programme. Availability at certified retail pharmacies is expected within 90 days. Until further notice, healthcare providers and patients should continue to utilize the current certified mail-order network.

Qsymia is approved in the US and is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol.

The effect of Qsymia on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, have not been established.

Vivus is a biopharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs in obesity, sleep apnea, diabetes and sexual health.