Orexigen Therapeutics, Inc. (OREX) FDA Approval Denied

By Tim - http://stockstobuy.org

The FDA has denied approval of a diet pill made by Orexigen Therapeutics, Inc. (OREX) this morning. Orexigen Therapeutics, Inc. (OREX) stock is tanking by 74% to $2.35.

FDA Issues Complete Response to New Drug Application for Contrave® for the Management of Obesity

Orexigen® Therapeutics, Inc. (Nasdaq:OREX - News) and Takeda Pharmaceutical Company Limited (Takeda) (TSE:4502.to - News) announced today that the United States Food and Drug Administration (FDA) has issued a complete response letter dated January 31, 2011 regarding the New Drug Application for Contrave® (naltrexone HCl/bupropion HCl) extended-release tablets for the treatment of obesity, including weight loss and maintenance of weight loss.

The FDA noted concern about the cardiovascular safety profile of naltrexone/bupropion when used long-term in a population of overweight and obese subjects. Specifically, the letter stated that "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."

So it looks like Orexigen Therapeutics, Inc. (OREX) will need to complete one more test before this drug can be approved. All hope is not lost but Orexigen will certainly have it's work cut out for them!

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