Contrave Diet Pill Approval Denied by FDA
Orexigen, the developer of the weight loss pill, Contrave™, announced that the Federal Drug Administration has issued a response letter on Contrave™. In the letter, the FDA showed concern over the possible long term effects of the naltrexone HCl/bupropion HCl combination drug on the cardiovascular systems of obese/overweight people who would be the primary users of Contrave™.
The FDA is requiring that a long term study be done and were quoted "before your application can be approved, you must conduct a randomized, double-blind, placebo-controlled trial of sufficient size and duration to demonstrate that the risk of major adverse cardiovascular events in overweight and obese subjects treated with naltrexone/bupropion does not adversely affect the drug's benefit-risk profile."
Expectations are that this requirement will push out possible approval of Contrave™ several years. Orexigen's stock (OREX) began the day at $9.09 and after the disapproval ended the day at $2.50, down 72.5%.
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The FDA is requiring that a long term study be done and were quoted "before your application can be approved, you must conduct a randomized, double-blind, placebo-controlled trial of sufficient size and duration to demonstrate that the risk of major adverse cardiovascular events in overweight and obese subjects treated with naltrexone/bupropion does not adversely affect the drug's benefit-risk profile."
Expectations are that this requirement will push out possible approval of Contrave™ several years. Orexigen's stock (OREX) began the day at $9.09 and after the disapproval ended the day at $2.50, down 72.5%.
Technorati Tags: Contrave™ naltrexone Diet Pills Weight Loss Pillsbupropion Diet Weight Loss Losing WeightEmpaticFDA
Labels: bupropion, contrave, diet pill, empatic, fda, food and drug administration, losing weight, naltrexone, orexigen, weight loss, weight loss pills
posted by Ken MacKenzie @ 4:00 PM
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