Good News for Qnexa
The most promising diet pill to come along in decades has received good news from the food and drug administration. The US Food and Drug Administration (FDA) have asked the company to remove the contraindication from the drug’s label, which had indicated that the drug cannot be used for the treatment of women of childbearing potential. Though, the contraindication for pregnant women remains.
Qnexa which is a combination of the diet pill Phentermine and the anti-epilepsy pill Topiramate was resubmitted for review in October 2011. The resubmission followed the company’s agreement with the FDA’s Endocrine and Metabolic Division in September 2011. The NDA resubmission included a proposed Risk Evaluation and Mitigation Strategy (REMS). Vivus the parent company producing Qnexa is revising its proposed REMS based on the change in Qnexa’s label.
While this removal does not guarantee approval, it is a strong indication that it may get approved when it comes up for review in April 2012. Qnexa still has some hurdles to overcome it does have many side effects most notably increased anxiety, sleep disturbances, dry mouth, tingling, constipation, altered taste, depression as well as the many side effects that come along with using Phentermine.