Vivus Inc. announced today that the Food and Drug Administration (FDA) has approved its anti-obesity drug, Qnexa, which has been renamed Qsymiatm . Qsymiatm 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, Osymiatm 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/