Vivus Inc said the FDA has asked the company to remove a contraindication in the proposed label of its obesity drug Qnexa, a move that could help it reach a broader patient population.…
The U.S. health regulator asked Vivus to remove the Qnexa contraindication for women of child-bearing potential. However, Qnexa will remain contraindicated for women who are pregnant.
The company is currently revising its proposed risk evaluation and mitigation strategy based on the change in the contraindication and plans to discuss details during an upcoming panel meeting.
Qnexa contains topiramate, which is used to treat migraine and epilepsy, and last month, data from a trial showed topiramate posed risks for pregnant women. It also contains phentermine.
Vivus, which has faced multiple regulatory hurdles on Qnexa, had resubmitted a marketing application for the drug with a narrower indication that excludes women of childbearing potential, in October, a year after regulators rejected it and sought data to prove Qnexa did not increase heart risks.
Obesity drug developers Arena Pharmaceuticals, Orexigen Therapeutics and Vivus have hit several roadblocks in recent times as the FDA has set a high bar for treatments that are likely to be taken by a large number of people.
While Arena’s investigational drug lorcaserin has been connected to possible cancer risks, Orexigen’s investigational Contrave (naltrexone SR/bupropion SR) was sent back on heart safety concerns.
Vivus news release, Jan 22, 2012