Contrave Reviews

Contrave is a diet drug that is currently working on making its way to the prescription drug shelves in the United States. It has not yet received its FDA approval, but it is in the midst of the process of doing so. It is a brand name for a combination of two generic drugs: bupropion and naltrexone.

This medication has been developed by a pharmaceutical company called Orexigen Therapeutics, Inc. It is meant specifically as an obesity treatment, which means that it is not designed simply for cosmetic weight loss. It is geared for individuals who are obese and who cannot bring their weight down through diet and exercise alone, but whose excess weight is placing them at an increased risk of a number of different health conditions such as high blood pressure, diabetes, and high cholesterol.

The combination of the drugs in Contrave are currently considered to be an investigational therapy. The hope is that it will help to treat the physiological and behavioral drivers that can lead to obesity.

Among the latest announcements that have been made by the manufacturer regarding the progress that Contrave is making, is that Orexigen has announced the PDUFA action date of June 10, 2014. As of January 7, 2014, the company announced that while the FDA considers the latest resubmission of the new Drug Application for this pill, which was a full response to the previous action letter from the FDA, which was made on January 31, 2011. The Prescription Drug User Fee Act goal date that was assigned by the FDA regarding this resubmission, was June 10, 2014. This means that if the FDA does actually give its approval for this medication, then the North American partner of Orexigen, Takeda Pharmaceuticals, will be able to legally launch Contrave in the United States as early as the second half of this year.

Though the approval of the drug is far from assured, Orexigen’s CEO, Michael Narachi, is dedicated to working “closely with the FDA” throughout the length of the review of the resubmission.

The Contrave Light Study which was previously announced in December 2013 was the drug’s cardiovascular outcomes trial, and which was considered to be successful in its interim analysis. It was a placebo-controlled, double-blind trial on the cardiovascular outcomes of the drug and involved a randomized group of 8,900 subjects. This was required by an FDA Special Protocol Assessment at about 260 different U.S. clinical sites. Its purpose was to rule out the possibility that overweight and obese patients who use Contrave could be placing themselves at an excessive cardiovascular risk.

Before this study, research on this drug included clinical trials involving over 4,500 people among whom 53 percent who used Contrave and 21 percent who used a placebo lost 5 percent or more of their body weight throughout a period of 12 months. Many of the drug’s users also experienced an improvement in their blood sugar and cholesterol levels.

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