SAN DIEGO, June 6 /PRNewswire-FirstCall/ -- Orexigen(R) Therapeutics, Inc. , a biopharmaceutical company focused on the treatment of obesity, today announced positive secondary findings from the first of four Phase 3 trials of its lead investigational product Contrave(R) (naltrexone sustained release (SR)/bupropion SR). These data were presented in one oral and two poster presentations at the American Diabetes Association's (ADA) 69th Scientific Sessions in New Orleans, Louisiana.
The oral presentation highlighted the significant improvements in eating control experienced by patients treated with Contrave versus placebo (p< 0.01), as well as previously reported results on the primary weight loss endpoints and measures of cardiometabolic risk. "NB-302 results show that Contrave initiates and sustains weight loss and can improve predictive markers for heart disease such as waist circumference, triglycerides, HDL-cholesterol and hsCRP," said Eduardo Dunayevich, Chief Medical Officer, Orexigen Therapeutics. "Furthermore, due to its unique effects on brain reward centers, Contrave may allow patients to better control their eating habits, potentially providing an important advantage to millions of Americans who struggle with obesity."
The mood and weight-related quality of life findings observed in the Contrave group were discussed in the oral presentation and reviewed in greater detail in the poster presentations. Contrave was not associated with suicidality or worsening of mood or depressive symptoms, and in fact was associated with a decreased incidence of treatment-emergent depression compared to placebo. In addition, Contrave patients achieved significant improvements in overall quality of life (p< 0.01) and reported that benefits, such as improved physical function and self-esteem, occurred early in treatment and were maintained over one year.
Results from the three other Phase 3 trials (NB-301, NB-303, NB-304) are expected to be announced in the third quarter of 2009. Pending positive results, the Company is on track to submit a New Drug Application (NDA) with the FDA in the first half of 2010.
About NB-302
NB-302 was a 56-week, double-blind, placebo-controlled trial, conducted in 793 patients at nine U.S. centers. The trial evaluated the additional weight loss of Contrave (32mg naltrexone SR/360mg bupropion SR) when added to an intensive behavior modification program consisting of counseling, diet and exercise. The co-primary endpoints were percent change in total body weight from baseline and proportion of patients who lost at least 5% of their baseline body weight.
Based on pre-specified intent-to-treat and completer analyses, obese patients treated with Contrave lost an average of 20.3 pounds to 25.0 pounds, or 9.3% to 11.5% of their baseline body weight, versus 11.0 pounds to 16.0 pounds, or 5.1% to 7.3% of baseline body weight, for patients treated with placebo. In addition, in the categorical weight reduction analysis, the percentage of patients who lost greater than or equal to 10% of their body weight was 41.5% in the Contrave group, compared to 20.2% in the placebo group. Furthermore, 29.1% of patients lost greater than or equal to 15% of their body weight in the Contrave group; compared to 10.9% in the placebo group. All of these findings were highly statistically significant (p< 0.001).
"NB-302 demonstrates that Contrave delivers greater weight loss to patients when added to a rigorous behavioral intervention program compared to the intervention program alone, underscoring the important role of pharmacotherapy as part of a weight management program," said Michael Narachi, President and Chief Executive Officer, Orexigen Therapeutics. "These data, which we believe meet the FDA efficacy guidance at the more stringent 10% threshold, also provide further support of Contrave's potential as a weight loss treatment for clinicians and their obese patients."
The overall discontinuation rate due to adverse events in NB-302 was 25.9% for patients taking Contrave versus 13.0% for those taking placebo. The most frequently observed adverse events leading to discontinuation for patients on study drug were nausea, urticaria (hives) and anxiety.
Contrave was generally well tolerated, with an overall safety profile consistent with its individual components, naltrexone and bupropion, two drugs that have been used separately for over 20 years. The discontinuation rate due to nausea was 4.6%. This rate is lower than what was seen in the Phase 2 trial (NB-201), which utilized the immediate release formulation of naltrexone as opposed to the proprietary SR formulation used in this trial. The most frequently observed treatment-emergent adverse events for patients on study drug were nausea, headache, constipation and dizziness.
About Contrave(R)
Contrave is an investigational oral weight loss medication with a unique mechanism of action that works at two levels within the central nervous system: one associated with controlling the balance of food intake and metabolism and another involved in controlling food preference, reward and cravings. We believe that Contrave may be the first treatment for obesity to target these reward centers in the central nervous system. Based on clinical trials completed to date, Contrave is believed to initiate and sustain significant weight loss over one year of treatment by reducing appetite, increasing metabolism and allowing the body to continue losing weight by offsetting its natural tendency to fight back and slow down the weight loss process.
About Orexigen(R) Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. The Company's lead combination product candidates targeted for obesity are Contrave(R), which is in Phase 3 clinical trials, and Empatic(TM), which is in the later stages of 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. Further information about the Company can be found at http://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 efficacy and safety of Contrave, the enrollment, timing, execution and completion of clinical trials of the Company's product candidates, the potential for, and timing of, an NDA submission for Contrave, and the potential to obtain regulatory approval for, and effectively treat obesity with, Contrave and Empatic. 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 final analyses of data from the NB-302 trial and other clinical trials of Contrave may produce negative or inconclusive results, or may be inconsistent with previously conducted clinical trials, and the FDA may not agree with Orexigen's interpretation of efficacy and safety results; earlier clinical trials may not be predictive of future results; Contrave or Empatic may not receive regulatory approval on a timely basis or at all, and the FDA may require Orexigen to complete additional clinical, non-clinical or other requirements prior to the submission or the approval of NDAs for either product candidate; the potential for adverse safety findings relating to Contrave or Empatic to delay or prevent regulatory approval or commercialization, or result in product liability claims; the third parties on whom Orexigen relies to assist with the development programs for Contrave or Empatic, including clinical investigators, contract laboratories, clinical research organizations and manufacturing organizations, may not successfully carry out their contractual duties or obligations or meet expected deadlines, and the quality or accuracy of the data or materials generated by such third parties may be of insufficient quality to include in the Company's regulatory submissions; the ability of Orexigen and its licensors to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of its product candidates; 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.
Orexigen Therapeutics, Inc.
CONTACT: Graham Cooper of Orexigen, +1-858-875-8600; or Media, Lori
Rosen, +1-212-301-7173, for Orexigen
Web Site: http://www.orexigen.com/
