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

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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.

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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.

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