Vivus’ Qsymia (formerly Qnexa) Wins FDA Approval Without Onerous Restrictions, Take-Out Speculation Likely to Drive VVUS Shares Higher

Vivus (NASDAQ:VVUS) announced FDA approval of its anti-obesity drug, Qsymia, last night and importantly, physicians can prescribe the medicine to patients without major restrictions. The drug’s label requires women of childbearing age to take a pregnancy test before getting a prescription, but other than that and a patient leaflet on the possibility of birth defects, Qsymia is prescribed similarly to Arena’s  (ARNA) recently approved obesity treatment, Belviq.  This is good news for VVUS shareholders, as it is in-line with best case scenarios for the drug’s approval. Additionally, because Qsymia already has a DEA controlled-substance classification, the product is likely to be on pharmacy shelves sooner that Belviq, which still has about 5 months left for its DEA controlled-substance review.