Vivus Submits REMS Amendment To FDA For Qsymia

Vivus announced that it has submitted an amendment to the Risk Evaluation and Mitigation Strategy (REMS) for Qsymia (phentermine and topiramate extended-release) capsules CIV. 

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.

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/m2 (obese) or ≥27 kg/m2 or (overweight) in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes or high cholesterol.

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