FDA Advisory Committee recommends Qnexa(Vivus Inc.) for treatment of Obesity

The FDA Endocrinologic and Metabolic Drugs Advisory Committee has voted 20-2 that the benefits of Qnexa (phentermine/topiramate) from Vivus Inc.,outweigh the risks in the treatment of Obesity. The committee recommended that Vivus should conduct a post-marketing study with regards to the potential cardiovascular side effects of Qnexa. The company has also proposed a risk evaluation and mitigation strategy which includes a plan to only allow 10 US mail-order pharmacies to distribute the drug and Vivus will train the prescribers and distribute warning pamphlets if the FDA grants approval; a final decision is due around April 17.