Anti-Obesity Drug Slated for FDA Review

Anti-obesity drug, Qnexa, is set to go in front of an FDA advisory panel in July.  Makers of Qnexa hope it will be available by the end of the year. 

Americans who continually struggle to battle the bulge could soon find help in a new weight loss pill. An experimental anti-obesity drug called Qnexa (Q-NEX-uh), manufactured by Vivus Inc., will be the subject of an FDA advisory panel review in mid-July.

The once-a-day drug is a combination of the popular anti-seizure and migraine medicine Topamax® and phentermine, a popular amphetamine weight loss drug. Researchers have completed the phase 3 program for Qnexa, including two pivotal, year-long phase 3 studies. During the clinical trials, patients taking Qnexa lost up to 37 pounds and saw significant improvements in weight-related medical conditions, including hypertension and diabetes.

Moreover, preliminary studies showed that it may also be effective in reducing sleep apnea, although the sleep-apnea data were only based on a small set of patients. Even so, the results could help Qnexa eventually become the first drug for the condition.

The Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee is scheduled to review Qnexa on July 15th, according to Vivus, and it’s believed the FDA will take action on the New Drug Application this October. Qnexa likely will only be offered by prescription, and could be available to the public by the end of the year.

Arena Pharmaceuticals has also filed for FDA review of its experimental weight loss drug, lorcaserin. Regulators are expected to make a decision by October 22nd. We’ll keep you posted on new developments.

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