On April 16, the FDA approved a modification of VIVUS’ Risk Evaluation and Mitigation Strategy (REMS), to allow sales of the Rx obesity drug Qsymia in retail pharmacies. REMS are established by the FDA when drugs are potentially harmful. Initially, the FDA told VIVUS that it would only be able to sell Qsymia at mail order pharmacies.
The modified REMS will help boost sales of Qsymia, since patients are used to picking up prescriptions at pharmacies rather than ordering them via a mail-order pharmacy. The change will also make things easier for the physician. However, VIVUS still faces hurdles to get insurers to pay for the drug.