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Phase III Clinical Program Remains on Schedule for Anticipated NDA. Filing in Late 2009
SAN DIEGO, CA, USA | May 07, 2008 | Orexigen(R) Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of central nervous system disorders, including obesity, today announced completion of enrollment in NB-303 and NB-304, the final two Phase III clinical trials for Contrave(R), its lead obesity product candidate. Today's announcement marks the completion of patient enrollment for the full Contrave Phase III program, keeping Contrave on track for an NDA submission to the FDA in late 2009. The Contrave clinical development program includes four Phase III clinical trials evaluating a variety of obesity and metabolic-related outcome measures. Orexigen previously announced that enrollment was completed in NB-301 and NB-302.
NB-303 is a placebo-controlled, 56-week clinical trial designed to analyze the efficacy, safety and tolerability of Contrave at the expected standard dose with the opportunity for patients to switch to a higher dose if they do not respond after 28 weeks of therapy. This trial is being conducted at 36 centers nationwide and has randomized approximately 1495 patients.
NB-304 is a placebo-controlled, 56-week clinical trial designed to analyze the efficacy, safety and tolerability of Contrave in obese patients with Type II diabetes. Recent studies have demonstrated that obesity is a leading risk factor for diabetes, and this trial is designed to evaluate weight loss and factors related to glucose metabolism. This trial is taking place at 51 centers nationwide and has randomized approximately 500 patients.
"Completing enrollment for the entire Contrave Phase III program on schedule is a profoundly important milestone for the Company. Equally important has been the attention given to the quality execution of these studies by both the Orexigen team and our clinical investigators," said Orexigen President and CEO, Gary Tollefson, MD, Ph.D. "Beyond the standard measures of efficacy, safety and tolerability, we have designed the Contrave Phase III clinical trials to address a number of the key secondary metabolic and behavioral endpoints that complicate are often associated with obesity."
Orexigen previously announced completion of enrollment in its NB-301 trial in November 2007 and its NB-302 trial in April 2008. NB-301 is a placebo-controlled, 56-week clinical trial designed to analyze the efficacy, safety and tolerability of two doses of Contrave in generally healthy obese patients. NB-302 is a placebo-controlled, 56-week clinical trial designed to analyze the efficacy, safety and tolerability of Contrave when combined with an intensive behavior modification protocol.
Contrave is a proprietary fixed dose combination of bupropion sustained release (SR) and the Company's novel formulation of naltrexone SR in a single tablet. Orexigen chose these two constituent drugs based on preclinical data that suggested that they act synergistically to initiate and sustain weight loss. Results from the first Phase III clinical trial are anticipated in late 2008 or early 2009.
About Orexigen Therapeutics
Orexigen(R) Therapeutics, Inc. is a biopharmaceutical company focused on the development of pharmaceutical product candidates for the treatment of central nervous system disorders, including obesity. Orexigen's lead combination product candidates targeted for obesity are Contrave(R), which is in Phase III clinical trials, and Empatic™, which is in the later stages of Phase II clinical development. Both product candidates are designed to take advantage of the company's understanding of how the brain appears to regulate appetite and energy expenditure, as well as the mechanisms that come into play to limit weight loss over time. 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.
SOURCE: Orexigen(R) Therapeutics, Inc. |
