SAN DIEGO, March 31 Orexigen® Therapeutics, Inc. (Nasdaq: OREX) today announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Contrave® (naltrexone SR/bupropion SR), its investigational drug for the treatment of obesity. The NDA is based on a substantial body of evidence gathered through the Contrave Obesity Research (COR) clinical program, which included over 4,500 patients.
"The COR program was designed to address all the elements of the FDA guidance for weight loss and weight maintenance in patients with obesity. We believe that if approved, Contrave has the potential to serve the diverse needs of obese patients who currently have few treatment options," said Mike Narachi, President and CEO of Orexigen. "I want to extend my appreciation to the Orexigen team as well as the investigators and patients who participated in the COR program, which provided the high quality data supporting the submission."
Below are highlights from the COR program reported previously:
The safety profile of Contrave® was found to be consistent with the safety of the two approved active ingredients. The most common adverse reactions (greater than or equal to 5% and at least twice the incidence of placebo patients) were nausea, constipation, vomiting, dizziness and dry mouth. Serious events were reported infrequently and included events of cholecystitis (NB 0.2%, PBO <0.1%), seizure (NB <0.1%, PBO 0%), and major cardiovascular events (NB <0.1%, PBO <0.1%).
"Having achieved this important milestone, we can now focus for the remainder of 2010 on managing the review and approval process for Contrave with the FDA, preparing for the launch of Contrave, and partnership," said Mike Narachi.
About the COR Phase 3 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, including a four week titration period. The co-primary endpoints were the proportion of patients achieving at least 5% weight loss and percent change in body weight compared to placebo. These endpoints were calculated based on intent-to-treat (ITT) last observation carried forward (LOCF) analyses of all randomized patients who had at least one post-baseline observation while on study drug. Secondary endpoints included multiple measures of cardiometabolic risk, quality of life, and control of eating, as well as HbA1c in the COR-Diabetes 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.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. In addition to Contrave, the Company's second product, Empatic(TM), 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 http://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 to obtain regulatory approval for, and effectively treat obesity with Contrave. 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: risks inherent in the uncertainty of the FDA approval process and other regulatory requirements; the therapeutic and commercial value of Contrave and Empatic; reliance on third parties to assist with the development of Contrave and the regulatory submission related thereto; the potential for adverse safety findings relating to Contrave or Empatic; the potential to enter into and the terms of any commercial partnership or other strategic transaction 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. 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.
-- Contrave clearly met the FDA efficacy benchmark: 48% and 56% of patients on Contrave32 lost at least 5% of their body weight in COR-I and COR-II on an intent-to-treat basis, as compared to 16% and 18% of placebo patients who lost at least 5%, respectively (p<0.001). -- Significant improvements were observed in cardiometabolic risk factors such as waist circumference, visceral fat, C-reactive protein, HDL cholesterol and triglycerides. -- In the COR-Diabetes trial, patients with type 2 diabetes experienced significant weight loss and demonstrated meaningful reductions in HBA1c. Specifically, 45% of patients on Contrave32 lost at least 5% of their body weight on an intent-to-treat basis, compared to 19% of patients on placebo (p<0.001). Contrave patients also showed a 0.6% reduction in hemoglobin A1c (HbA1c) from baseline, compared to a 0.1% reduction in placebo (p<0.001). -- Patients treated with Contrave demonstrated statistically significant improvement in quality of life, and in self reported exploratory measures of control of eating.
SOURCE Orexigen Therapeutics, Inc.