Contrave® Weight Loss Drug Information

Contrave®

     One of the other medications for obesity that is going through trial stages of testing is one called Contrave® its manufacturer is Orexigen Therapeutics Inc. But interestingly it is actually just a combination of two already approved and existing drugs for other ailments. These already existing medications are the antidepressant Wellbutrin® (or also known as bupropion which has also been used as a smoking cessation). The other is a drug they use for addictions (primarily alcohol, street drugs etc) named Revia® or Vivitrol® or generic name Naltrexone. During phase 2 testing different dosages where used in a once daily formula these include:

(16 mg naltrexone *IR - 400 mg bupropion *SR)
(32 mg naltrexone *IR - 400 mg bupropion *SR)
(48 mg naltrexone *IR - 400 mg bupropion *SR)

*IR= Immediate Release
*SR=Sustained Release

The (32 mg naltrexone *IR / 400 mg bupropion *SR) on average showed the best benefit to risk ratio thus making it a favorite.

However it should be noted that the actual Contrave® being used in phase 3 trials, and is most likely the one to be used, has an Orexigen developed naltrexone SR to make the drug more tolerable. Contrave® = (naltrexone SR / Bupropion SR)

     In other testing back in June of 2007 Orexigen announced that after reviewing information from a phase 2 trial test with Contrave that patients demonstrated a 50% decrease in metabolic syndrome. Metabolic syndrome is a group of related disorders that increase the risk of developing metabolic/cardiovascular problems. These include things like high blood pressure, high insulin levels excess fat specifically around the waist etc. These can lead to a risk of developing diabetes and other weight related health problems.
After the 24 week period of testing Contrave for obesity it was pointed out that of the 31% of the people who had metabolic syndrome, 16% no longer experienced it. The patients on the placebo also had a decrease but a very minimal amount, their numbers went from 38% to 30%.
     Contrave works in the brain or hypothalamus where the control center for ones appetite is. Some people have seen decent weight loss with bupropion alone, but the combination is where the benefits of weight loss really get underway. And the fact that bupropion alone has not been FDA approved to be prescribed as a weight loss drug. In tests with a placebo + naltrexone, a placebo + bupropion, Contrave out did both. There have been clinical trials that have shown its effectiveness of Contrave including the phase 3 testing where more than 4500 patients going above the FDA's efficacy benchmark for clinically significant weight loss.
     On average, the participants lost between 9% to 15% of their body weight (in conjunction with the overall test that included some diet restrictions and exercise). This was much better than the patients that where in the placebo group. And according to the FDA, that constitutes as an amount that would allow it to be considered as a potentially approved obesity drug based on that finding alone. But these findings also come with some side effects for some of its users.
     Some of the potential side effects reported are mild to moderate nausea, some mid to moderate headaches and constipation some of which weakened, or disappeared after further use. This does not mean that Contrave is on its way to become approved. When and if Contrave is presented to the FDA for approval, the FDA will consider many different factors in its decision of approval or not. Some concerns are things like cardiovascular safety, and psychological issues.

July 21st, 2009
Orexigen announced that all three remaining phase 3 trials testing Contrave met their endpoints.

Dec 17th, 2009
News out that Orexigen Therapeutics plan on bringing Contrave before the FDA within months...

Jan 13th, 2010
Orexigen Therapeutics Inc, is currently in talks with some potential partners to help market the drug Contrave but stated today they are willing to go it alone if no suitable partner if found and are comfortable doing so. Contrave is expected to be submitted to the FDA for approval sometime early this year.

March 9th, 2010
Orexigen Therapeutics plans to file Contrave to the FDA for potential approval by the end of April.

Goto the Contrave Forum

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