ORLANDO, Fla., June 26 /PRNewswire-FirstCall/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX) today announced results from a 24-week open-label study demonstrating that treatment with Contrave® resulted in significant improvements in depressive symptoms that was accompanied by weight loss and improved control of eating in overweight and obese patients with major depression.
The primary endpoint of the study was the change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) at 12 weeks on an intent-to-treat (ITT) basis. Treatment with Contrave32 (32mg naltrexone sustained release (SR)/360mg bupropion SR) resulted in the MADRS score decreasing from an average of 23.7 at baseline (consistent with moderate depression) to 10.5 (mild depression) (p<0.001) at week 12 and further decreasing to 8.4 (remission) at week 24 (p<0.001). Patients who completed the study lost an average of 9.2% of total body weight and reported substantial reductions in hunger, strength and frequency of food cravings and demonstrated improved control of eating.
"Recent reports in the literature show that the risk of depression is higher in obese people and, at the same time, depression has been associated with increased obesity. In addition, obese women are more than twice as likely to be depressed as non-obese women. In this context, clinicians are in need of new tools to treat obese patients suffering from this common co-morbidity," said Dr. Susan McElroy, M.D., Lindner Center of HOPE, Mason, Ohio. "This study is the first step in assessing the value of Contrave in this important patient population and these positive results should encourage additional investigation."
In this study, the most common adverse events were nausea, constipation, headache and insomnia, and, in general, were consistent with past experience in the COR program. There were no serious adverse events reported by the investigator as related or possibly related to Contrave in the trial.
Contrave is an investigational combination therapy believed to address both physiological and behavioral drivers of obesity. The two components of this combination therapy act in a complementary manner in the central nervous system. The central pathways targeted by this treatment are involved in controlling the balance of food intake and metabolism, and regulating reward-based eating behavior. In clinical trials, Contrave was shown to help obese patients initiate and sustain significant weight loss, improve important markers of cardiometabolic risk and increase ability to control eating.
The U.S. Food and Drug Administration (FDA) has tentatively scheduled a Division of Metabolic and Endocrine Drug Products Advisory Committee meeting on December 7, 2010 and the Prescription Drug User Fee Act (PDUFA) action date has been set for January 31, 2011.
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. 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%, PBO <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. Further information about the Company can be found at www.orexigen.com.
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 Company's belief that this product candidate may be an important therapeutic option in the treatment of obesity. 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: the uncertainty of the FDA approval process and other regulatory requirements; the therapeutic and commercial value of Contrave; reliance on third parties to assist with the development of Contrave; the potential for adverse safety findings relating to Contrave; 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 the Company's Quarterly Report on Form 10-Q, which was filed with the Securities Exchange Commission on May 10, 2010 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.