Orexigen(R) CFO to Resign After Contrave Rejection

About a week after Orexigen^® announced cuts of about 40% of their workforce in the aftermath of the FDA's response letter requiring further studies bfore Contrave^® could be approved, Graham Cooper, senior vice president, Finance, CFO and treasurer has announced that he will resign.

Cooper, who has been with Orexigen^® since 2006, is leaving for personal reasons. He will remain in his current position until the year-end results are in and the annual report has been filed with the Securities and Exchange Commission. Jay Hagan, who is the senior vice president, Corporate Development and Strategy, will take over as the interim CFO.

Orexigen Therapeutics, Inc. (OREX) stock price closed the week at $3.29.

Technorati Tags: Contrave™ naltrexone Diet Pills Weight Loss Pillsbupropion Diet Weight Loss Losing WeightEmpaticFDA

Orexigen Cutting Jobs to Conserve Cash

Orexigen^(R) Cuts Jobs Due to FDA Response Letter

Orexigen^(R) Therapeutics, Inc. staff will be reduced by about 40% to conserve cash after the Food and Drug Administration didn't approve Contrave^™ requesting further studies on the long term effects of the drug on patients' cardiovascular systems. Mike Narachi, Orexigen's CEO, stated in a press release "We continue to believe in the potential of Contrave and look forward to discussions with the FDA. Unfortunately, given the near term uncertainty of Contrave^™ approval, we felt it prudent to consolidate and focus our resources. We are deeply grateful for the dedication and tremendous effort provided by all of our colleagues who are impacted by this realignment."

As expected, Orexigen's (OREX) stock price took a hit after the FDA decision, dropping from the $8-9 range back to under $2.50 before coming back to Friday's close of $3.32.

Technorati Tags: Contrave™ naltrexone Diet Pills Weight Loss Pillsbupropion Diet Weight Loss Losing WeightEmpaticFDA

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%.


Technorati Tags: Contrave™ naltrexone Diet Pills Weight Loss Pillsbupropion Diet Weight Loss Losing WeightEmpaticFDA

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.

Technorati Tags: Contrave™ naltrexone Diet Pills Weight Loss Pillsbupropion Diet Weight Loss Losing WeightEmpaticFDA

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.

Technorati Tags: Contrave™ naltrexone Diet Pills Weight Loss Pillsbupropion Diet Weight Loss Losing WeightEmpaticQnesalorcaserin

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.

Contrave Diet Pills

Contrave's Fate to be Decided by FDA Panel Dec 7

Contrave™ will have it's day on Tuesday, December 7 when an FDA panel of experts vote to approve it or send it back to the drawing board. The Food & Drug Administration released information on Friday sending mixed signals about Contrave™. The drug definitely helped users lose weight, but may not have reached the required FDA standards.

The FDA information also raised questions about potential side effects. Since two other weight loss drugs (Qnexa™and Lorcaserin™) failed to gain approval from the FDA panel of experts earlier this year and were not approved for use by the FDA, many experts are not too optimistic on Contrave™'s chances.

Here is a link to the FDA's recently published information on Contrave™ for the upcoming panel meeting. Orexigen Briefing Information for the December 7, 2010 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee

Technorati Tags: Contrave™ naltrexone Diet Pills Weight Loss Pillsbupropion Diet Weight Loss Losing Weight

Latest Updates on Contrave

Contrave™, one of Orexigen's entries in the diet drug market, is set for an FDA panel review in December. The recent removal of Meridia™ from the marketplace by the FDA makes it seem as though any new diet drug is going to have to have almost no side effects to gain approval. Two other new diet drugs, Lorqess and Qnexa, were not recommended by recent FDA advisory panels.

Technorati Tags: Contrave™ naltrexone Diet Pills Weight Loss Pillsbupropion Lorqess Qnexa Meridia

Orexigen™ begins third trial in Phase III clinical trial program

Orexigen™ Therapeutics, Inc. announced on October 17, the start of the third of four trials in its Phase III clinical trial program for Contrave™, one of it's two promising weight loss drugs.

This clinical trial is a 58-week study designed to assess the safety, tolerability and efficacy of Contrave™ in otherwise healthy, nondiabetic, obese patients. The trial is designed to take place at approximately 40 centers nationwide and will include about 1650 patients.

The first Phase III clinical trial for Contrave™ started enrolling subjects in April and is scheduled to run for 56 weeks and will test weight loss potential either alone or combined with intense diet, exercise and behavior modification.

The second Phase III trial started enrolling subjects in May. It's also scheduled to run 56 weeks and will be testing obese subjects with Type II diabetes.

The fourth Phase III trial is scheduled to begin enrollment sometime during the fourth quarter of 2007.

For more information, please visit http://ir.orexigen.com/releasedetail.cfm?ReleaseID=269637

Technorati Tags: Contrave™ naltrexone Diet Pills Weight Loss Pillsbupropion

Orexigen™ Preclinical Results Show Contrave™Acts on Specific Pathways in the Brain to Reduce Food Intake

Orexigen™ Therapeutics, Inc. announced on October 23, 2007, that preclinical tests showed that a combination of bupropion and naltrexone (the two drugs making up the Orexigen™ drug Contrave™) resulted in a 94% reduction of food intake in obese mice, greater than either drug alone, and as much as 77% reduction in lean mice.

For more information on this press release, go to http://ir.orexigen.com/releasedetail.cfm?ReleaseID=270737.

Technorati Tags: Contrave™ naltrexone Diet Pills Weight Loss Pillsbupropion

Orexigen™ Announces Positive Clinical Results of Its Proprietary Naltrexone Sustained Release Formulation for Use in Contrave™

On September 25, 2007, Orexigen™ Therapeutics, Inc announced positive results for their two Phase I trials of a new sustained release formulation of naltrexone, which is the main ingredient in Orexigen's™ new weight loss drug Contrave™, which is currently in Phase III trials.

The first trial compared the immediate release naltrexone with the newer sustained release naltrexone. Results showed that the sustained release version reduced peak blood concentration by about 25% and fewer users had more than one adverse event.

The second trial included a combination of bupropion SR with either naltrexone SR or naltrexone IR. This is the drug combination used in Orexigen's™ diet drug Contrave™. The results showed that there were fewer adverse effects from the sustained release version, as opposed to the immediate release type.

Technorati Tags: Contrave™ naltrexone Diet Pills Weight Loss Pillsbupropion