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Orexigen Therapeutics Presents Additional Contrave Data from Phase 3 COR-II Trial on 24-Hour Ambulatory Blood Pressure Monitoring

Update: Contrave (bupropion/naltrexone) Now FDA Approved - September 10, 2014

-Results Presented at the 60th Annual Scientific Session of the American College of Cardiology-

NEW ORLEANS, April 4, 2011 /PRNewswire/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX) announced additional data that showed that overweight and obese patients treated with Contrave® (naltrexone sustained release (SR)/bupropion SR) maintained normal 24-hour circadian patterns over one year of treatment.  These data were from the ambulatory blood pressure monitoring (ABPM) sub-study of the COR-II trial that also showed weight loss and improvements in markers of cardiometabolic risk.  Data were presented at the 60th Annual Scientific Session of the American College of Cardiology (ACC) taking place in New Orleans.

"The observation that patients in this sub-study maintained normal circadian variation of blood pressure may be particularly relevant since a loss of the nocturnal lowering in blood pressure may predict a poor cardiovascular outcome," said Jorge Plutzky, M.D., Director of the Vascular Disease Prevention Program at Brigham and Women's Hospital.

Additional results showed Week 52 weight loss of 7.5% for subjects in the sub-study on Contrave as compared to 2.5% for subjects on placebo (P<0.001) and improvements, at Week 56, in waist circumference (-7.5cm vs. -2.3 cm; P<0.001), hs-CRP (-40.7% vs. -2.4%; P<0.01) and HDL-C (+4.4mg/dL vs. -0.6mg/dL; P<0.01) based on LOCF analyses.  

Study Design

The COR-II ABPM sub-study enrolled 182 of the 1496 subjects from the main trial, at nine U.S. sites.  Monitoring of ambulatory blood pressure in the sub-study was initiated prior to the intake of study drug and other morning medications and completed approximately 24-hours later at three time points during the study: baseline, Week 24 and Week 52. COR-II is one of the four Phase 3 trials supporting Orexigen's New Drug Application for Contrave.

About the Contrave Clinical Development Program

All four trials in the COR Phase 3 program (COR-I, COR-II, COR-BMOD and COR-Diabetes) were randomized, double-blind, placebo-controlled trials. The co-primary endpoints were the proportion of patients achieving at least 5% weight loss and percent change in body weight compared to placebo. Secondary endpoints included multiple measures of cardiometabolic risk, quality of life, control of eating, and glycemic control.  Contrave was generally well tolerated.  The safety and tolerability profile of Contrave in the clinical development program was consistent with the safety profile of the constituent components, which have been in use for other indications for over 20 years.  The most frequent treatment-emergent adverse events in patients treated with Contrave were nausea, constipation, headache, vomiting and dizziness.  These were mostly mild to moderate in severity, transient, and typically occurred during the first weeks of treatment.  The most common adverse events leading to discontinuation with Contrave were nausea, headache, dizziness and vomiting.  Treatment with Contrave was not associated with increases in adverse event reports of depression or suicidal ideation compared to placebo.  Mean blood pressure with Contrave was generally unchanged from baseline to endpoint.  Placebo patients experienced decreases in blood pressure from baseline to endpoint of approximately 2mmHg.  Greater weight loss correlated with greater reductions in blood pressure in both Contrave and placebo patients, suggesting that the expected relationship between weight loss and blood pressure was maintained.  Importantly, normal circadian blood pressure patterns were preserved with Contrave.  There was an increase in pulse of about one beat per minute in patients taking Contrave.  Serious events were reported infrequently and included events of cholecystitis (Contrave 0.2%, Placebo <0.1%), seizure (<0.1%, 0%) and major cardiovascular events (<0.1%, <0.1%).

About Orexigen Therapeutics

Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. The Company's lead product, Contrave, has completed Phase 3 clinical trials and has received a Complete Response Letter from the FDA for its New Drug Application.  The company is in the process of determining the next steps for Contrave.  The Company's second product, Empatic™, has completed Phase 2 clinical development. Each product candidate is designed to act on a specific group of neurons in the central nervous system with the goal of achieving appetite suppression and sustained weight loss, through combination therapeutic approaches. Further information about the Company can be found at www.orexigen.com.

Forward-Looking Statements

Orexigen cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed" and similar expressions are intended to identify forward-looking statements. These statements are based on the Company's current beliefs and expectations. These forward-looking statements include statements regarding the potential for, and timing of, approval for Contrave and the loss of the nocturnal lowering in blood pressure may predict a poor cardiovascular outcome.  The inclusion of forward-looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: Orexigen's ability to conduct a preapproval cardiovascular outcomes trial, Orexigen's ability to demonstrate that the risk of major adverse cardiovascular events in overweight and obese subjects treated with Contrave does not adversely affect the product candidate's benefit-risk profile; the potential for early termination of the collaboration agreement between Orexigen and Takeda; the costs and time required to complete additional clinical, non-clinical or other requirements prior to any resubmission of an NDA; the therapeutic and commercial value of Contrave; Orexigen's ability to attract and retain key personnel; Orexigen's ability to maintain sufficient capital; and other risks described in the Company's filings with the Securities and Exchange Commission.  You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Orexigen undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.  Further information regarding these and other risks is included under the heading "Risk Factors" in Orexigen's Quarterly Report on Form 10-K, which was filed with the Securities Exchange Commission on March 11, 2011 and is available from the SEC's website (www.sec.gov) and on our website (www.orexigen.com) under the heading "Investor Relations".  All forward-looking statements are qualified in their entirety by this cautionary statement.  This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

 

SOURCE Orexigen Therapeutics, Inc.

Posted: April 2011

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