Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Orexigen Therapeutics, a biopharmaceutical company, has announced that the first of four Phase III trials of its lead investigational product Contrave 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.
Subscribe to our email newsletter
In this trial, which included an intensive diet and exercise behavior modification regimen, obese patients treated with Contrave, based on intent-to-treat and completer analyses, lost an average of 20.3 pounds to 25 pounds, or 9.3% to 11.5% of their baseline body weight, versus 11 pounds to 16 pounds, or 5.1% to 7.3% of baseline body weight, for patients treated with placebo. Contrave was generally well tolerated by patients.
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. All of these findings were highly statistically significant and satisfy the categorical FDA efficacy benchmark for clinically significant weight loss, the company said.
The 56-week, double-blind, placebo-controlled trial conducted at nine US centers evaluated the efficacy and safety of Contrave (32mg naltrexone SR/360mg bupropion SR) compared to placebo in 793 obese patients who participated in an intense behavioral program consisting of counseling, diet and exercise. The objective of this NB-302 trial was to determine the additional weight loss and health benefits of Contrave when added to an intensive diet and exercise program.
Patient enrollment has been completed in the three other Phase III trials. Orexigen expects to announce top-line results from these trials in mid-2009 and, pending additional positive results, submit a new drug application with the FDA in late 2009.
Eduardo Dunayevich, chief medical officer of Orexigen, said: The results of this trial indicate that additional, clinically significant weight loss can be achieved when Contrave is added to a rigorous program of diet and exercise. We are also very pleased with the safety profile demonstrated by Contrave thus far.
We look forward to the results from the remaining Phase III trials which will further examine the efficacy, safety and tolerability of Contrave with less intensive behavior modification as well as in patients with type 2 diabetes patients.