The small pharmaceutical company Vivus is preparing to resubmit its diet pill Qnexa for approval from the FDA, however federal officials still have concerns. The FDA initially rejected the weight loss medication in October of 2010, due to concerns that taking the drug could increase the risk possible birth defects and heart problems.
Qnexa is a drug that combines two existing the appetite suppressant Phentermine and the anti-convulsant Topiramate. Vivus has gone through several rounds of research in the process of resubmitting its request to the FDA, and succeed in lifting the contraindication for women of child-bearing age, although the FDA is still worried about a possible link between Qnexa and cleft lip defects. The drug has also been shown to increase blood pressure and cause higher heart rates in some patients.
The FDA will hold a public meeting on Wednesday with experts to try to resolve these concerns. The panel of doctors will also decided if any additional research is required, and will take a vote on Qnexa’s safety, and the FDA is expected to make its final ruling in April. Vivus will offer to conduct a long-term follow-up study to monitor patients for heart events.
Qnexa had been flagged the most promising of three new weight loss medications, because in initial trials subjects lost an average of ten perfect of their starting body weight. Contrave, one of the other potential weight loss drugs, received the go-ahead for for more FDA-approved trials earlier this month.
New Contrave Trials Approved by FDA