FDA declines to approve Qnexa
MOUNTAIN VIEW, Calif. Vivus found itself foiled in its efforts to market a drug for obesity as the Food and Drug Administration turned down its regulatory approval application.
The company said Thursday that it received a complete response letter from the FDA for Qnexa (phentermine and topiramate) controlled-release capsules. The agency said the application can’t be approved in its current form and asked for additional study data. The FDA issues a complete response letter to indicate that it has completed review of an application, but questions remain that preclude final approval.
The prospects for the drug’s approval didn’t look good even before Vivus submitted its application, despite the drug showing some promise in clinical trials. In July, an FDA advisory committee voted 10-6 against recommending approval for Qnexa, citing such possible side effects as psychiatric problems and birth defects. Though an advisory committee’s vote does not determine whether the agency will approve a drug, its vote is taken into consideration.