MOUNTAIN VIEW, Calif.
Oct. 17, 2012
/PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) today announced that it has submitted an amendment to the Risk Evaluation and Mitigation Strategy (REMS) for Qsymia™. The proposed REMS modification would allow dispensing through a broader range of certified pharmacies, specifically select retail pharmacies, to increase access while meeting all requirements of the REMS. The REMS modification was made at the mutual request of VIVUS and the FDA.
Within the current REMS program,
Qsymia is available through certified mail order pharmacies that are part of the Qsymia Home Delivery Network, including CVS Pharmacy, Express Scripts and Walgreens. The REMS program includes a Medication Guide, healthcare provider training,
patient brochure and other education tools. These same tools also will be available as part of the proposed modified REMS program.
"Our REMS has been, and will continue to be, a key element in the Qsymia launch and we look forward to working with the FDA on the modification request," said Dr.
, Vice President of Scientific Communication & Risk Management at VIVUS.
Qsymia is FDA-approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 or greater (obese), or 27 or greater (overweight) in the presence of at least one weight-related comorbidity, such as hypertension, type 2 diabetes mellitus or high cholesterol (dyslipidemia). It is the first FDA-approved once daily combination therapy for the treatment of obesity.
Qsymia 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/m
or greater (obese) or 27 kg/m
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. There are certain limitations of use for Qsymia. 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.
Important Safety Information
Qsymia (phentermine and topiramate extended-release) capsules CIV is contraindicated in pregnancy; in patients with glaucoma; in hyperthyroidism; in patients receiving treatment or within 14 days following treatment with monoamine oxidase inhibitors (MAOIs); or in patients with hypersensitivity to sympathomimetic amines, topiramate, or any of the inactive ingredients in Qsymia.