As previously reported, seven serious adverse events were attributed by investigators as possibly related to Contrave treatment across the entire COR program. These include cholecystitis (gallbladder inflammation), seizure, palpitations, paresthesia and vertigo. The most frequently observed treatment-emergent adverse events were nausea, constipation and headache. Nausea was the leading adverse event resulting in discontinuation; however, for the majority of patients experiencing nausea, it was mild to moderate, transient and manageable.

At week 56, mean blood pressure was generally unchanged from baseline for Contrave patients compared to placebo patients, who tended to experience a slight decrease (approximately 2 mm Hg) from baseline. Contrave treatment did not appear to disrupt the normal circadian pattern of blood pressure. There was a slight increase in pulse (approximately 1 beat per minute) in Contrave patients compared to placebo patients, whose pulse was generally unchanged. There were no meaningful treatment effects on ECGs or laboratory measures including liver function tests. Treatment with Contrave was not associated with increases in symptoms of depression or suicidal ideation.

The Company is on track to submit a New Drug Application (NDA) for Contrave with the FDA in the first half of 2010.

Additional Presentations at The Obesity Society

Additional data including Intent-to-Treat (ITT) analyses from COR-I and COR-II will be presented as late-breaker presentations in the Marriott Ballroom Salon 2 on Tuesday, October 27, beginning at 11:00 am EST. In addition, three posters (220-P, 218-P, 216-P) featuring data from the COR-BMOD trial will be presented in the Marriott Exhibit Hall on Sunday, October 25 from 1-2 and 6:30-7:30 pm EST (posters available for viewing from 1-7:30pm).

SOURCE Orexigen Therapeutics, Inc.