Orexigen(R) Therapeutics (OREX) Announces 1st of 4 Phase 3 Trials of Contrave(R) Met Co-Primary and Key Secondary Endpoints
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Orexigen(R) Therapeutics, Inc. (Nasdaq: OREX) today announced that the first of four Phase 3 trials of its lead investigational product Contrave(R) (naltrexone sustained release (SR)/bupropion SR) met its co-primary and key secondary endpoints, showing a significant reduction in body weight, improvements in markers of cardiovascular risk and reductions in selected food craving measures.
In this trial, which included an intensive diet and exercise behavior modification regimen, obese patients treated with Contrave, based on intent-to-treat (ITT) and completer analyses, 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 20.2% in the placebo group compared to 41.5% in the Contrave group. We believe these results satisfy the categorical FDA efficacy benchmark for clinically significant weight loss. All of these findings were highly statistically significant (p<0.001).
Contrave was generally well tolerated by patients. The overall safety profile of Contrave was consistent with its individual components, naltrexone and bupropion, two drugs that have been used separately in patients for over 20 years. Treatment with Contrave was not associated with increases in symptoms of depression, suicidality or worsening of mean blood pressure.
Orexigen Therapeutics, Inc., a development stage company, operates as a biopharmaceutical company focusing on the development of pharmaceutical product candidates for the treatment of central nervous system disorders (CNS), including obesity.
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