Vivus Inc. announced today that the Food and Drug Administration (FDA) has approved its anti-obesity drug, Qnexa^, which has been renamed Qsymia^tm .  Qsymia^tm is a combination drug, composed of phentermine and topiramate, both of which have been approved by the FDA for years. As we have previously reported, Osymia^tm has the most impressive weight loss of any obesity drug. The FDA has recommended patients discontinue the drug if they lose less than 3% of body weight on the mid-dose formulation or less than 5% on the high dose after 12 weeks. They also recommended monitoring of heart rate for people on the drug and that women of child-bearing age have a negative pregnancy test every month while using the drug. A Risk Evaluation and Mitigation System (REMS) plan includes distribution through certified pharmacies, a medication guide and a timetable for assessments.

The Risk Evaluation and Management Strategy information, Medication Guide, Safety Information and Health Provider Training Program can be accessed at: http://www.qsymiarems.com/