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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Contrave Diet Pill FDA Decision Expected on Monday

The Contrave(R)diet pill being developed by Orexigen, Inc. will discover it's fate tomorrow when the FDA decides whether or not to approve the drug. In December, an FDA advisory committee voted to recommend Contrave(R) for approval.

The panel was split and they also noted that some further research is needed which in their opinion could be done once approval has taken place. During the recent past, the FDA has denied approval for a couple of new drugs and recommended that another weight loss drug be removed from the market, so it is far from a sure thing that Contrave(R) will make it on this try.

The FDA could deny the application outright, but this is less likely due to the committee approval. They could decide that the research needs to be completed prior to approval, which would send Orexigen back to the drawing board setting up some new trials. Finally they could approve Contrave(R) and allow the needed research to be done afterwards. This would be the easier way for Orexigen, since once it's on the market, there will be thousands of users available to get the required data from.

Approval here may also pave the way for Orexigen's other weight loss drug, Empatic(TM), which like Contrave(R) is a combination of two drugs which are already sold on the market for other things.

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Contrave Diet Pills Recommended. What's Next?

Contrave(R), a weight loss drug being developed by Orexigen(R) Therapeutics, Inc., was recommended by an expert panel of the FDA last week by a vote of 13-7. The vote surprised many who were expecting another defeat like those of lorcaserin and Qnesa earlier in the year.

There are questions about a possible link to cardiovascular issues, but the panel voted 11-8 to recommend that a study could be done post-approval, which could lead the way to FDA approval of Contrave(R) on January 31, 2011.

Orexigen(R) is also developing another weight loss product, Empatic(R), which may gain some attention and momentum from Contrave(R)'s approval.

Orexigen(R)'s stock zoomed from about $4.75 to more than $12.25 in after hous trading on the evening of the panel's decision, after trading had been halted for the day. On Wednesday, it floated back down to the $8-9 range where it has stayed, closing Friday at $8.43. With th possibility of approval in the fairly near future, the stock could see some interesting moves in the weeks ahead. For purposes of disclosure, I do not own any Orexigen(R) stock at the moment, though I could in the future.

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Weight Loss Pill CONTRAVE Gains Recommendation From FDA Panel

CONTRAVE has gained recommendation from the FDA's expert panel today by a vote of 13-7.

Orexigen's new entry into the weight loss arena gained the recommendation of the Food & Drug Administration's panel of experts this afternoon. Final approval will have to come from the FDA at a later time, but the FDA usually follows the lead of the panel.

More to come later.

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