Rejected Weight-Loss Drug Contrave Breathes Life into Orexigen
Rejected Weight-Loss Drug Contrave Breathes Life into Orexigen ,Wii video game consoles and accessories wholesale retail
San Diego-based drug maker Orexigen Therapeutics manufacturer of weight-loss drug Contrave has decided to proceed with a necessary study to get full approval from the FDA for consumer use.
Last year Food and Drug Administration advisory committees reviewed and rejected two different weight-loss drug applications Qnexa and Lorcaserin. Only one made it past committee Orexigen Therapeutics Contrave. Then earlier this year Contrave looked to get full approval from the FDA. But the REJECT stamp was used once again due to concerns about long-term use and heart problems.
However there was a small glimmer of hope. Orexigen Therapeutics received a letter from the FDA that called for a long-term study of the drug, saying specifically that before your application can be approved you must conduct a randomized double-blind placebo-controlled trial of sufficient size and duration to demonstrate that the risk of major adverse cardiovascular events in overweight and obese subjects treated with does not adversely affect the drugs benefit-risk profile.
Contrave is a combination drug that targets behavior and reward pathways in the brain. It combines the antidepressant Wellbutrin with naltrexone an opioid blocker used to treat alcoholism and opiate addiction. It is one of the first drugs to address the issue of craving that many overeaters experience.Results of late-stage clinical trials for Contrave showed that the drug quelled cravings and promoted weight loss more than more than satisfying the effectiveness requirement of the Food and Drug Administration
