Contrave

Mysimba (Contrave-Naltexone plus bupropion in the EU) now approved for weight loss

Mysimba for weight loss- It is the name for Contrave (naltrexone and bupropion) in Europe. This drug is the newest weight loss drug and had an unusual release of data. What appears to be shown in early data is that it may have a direct effect/benefit in decreasing risk of heart attack.

Weight loss drug decreases heart attacks? Contrave and early data

 

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fireworks A study of 4,500 patients using a new weight loss drug called Contrave (bupriprion and naltrexone) had the expected effect of a weight loss benefit, and the drug was FDA approved. A study of 8,910 people in a follow up study had the weight loss benefit, however; the patients taking Contrave had fewer heart attacks than the people who didn't take it.

There is controversy over this trial and apparent early leaks of data, but the information that patients taking the drug had fewer heart attacks is stunning. Importantly, the researchers doing the study thought the benefit on heart attacks may be a direct effect of the drug combination!

More to follow as always.

Contrave and cardiology--could this newer weight loss drug help your heart too?

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food Contrave (bupropion and naltrexone) is apparently unique. The SEC disclosed that the US patent office gave the 371 patent to Orexigen Therapeutics based on an interim look at the LIGHT study. What this means is that Contrave has a claim for having a POSITIVE IMPACT on cardiovascular results (outcomes) beyond (unrelated to) weight loss.

More to come and most probably from the American College of Cardiology meeting in San Diego this month. Regardless, having strength in weight loss AND HEART disease is a true breakthrough in medicines.

Where's the beef? FDA rejects Contrave combination of two FDA approved medicines

two women angry IN a suprise move, the FDA decided against the advice of its own expert panel and apparently has postponed approval of the new weight loss drug called Contrave. The shocking aspect of this action is that Contrave is a combination of two medicines WHICH ARE ALREADY APPROVED BY THE FDA.

Waiting for weight loss and Contrave

woman with blue face Are you getting blue in the face waiting for a new prescription weight loss drug? Today may be your day. The expert advisory committee of the FDA (Endocrine and Metabolic) recommended that the FDA approve Contrave.

Approval Date: 
Mon, 01/31/2011
Company: 
Orexigen

Contrave and long wait for a new weight loss drug is probably over

food on plate The Endocrine and metabolic committee of the FDA recommended 13-7 to approve the first weight loss drug since 1999. Contrave (a combination of bupropion and naltrexone) was recommended for approval and while the FDA usually follows the vote of its expert committees, it is not bound to do so.

Contrave Controversy at the FDA

convention center The questions have been set for the Endocrine and Metabolic Advisory Committee meeting tomorrow and it looks like Contrave (bupropion plus naltrexone) will have some challenges facing benefits versus risks and may be required to have followup or additional studies performed.

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convention center The questions have been set for the Endocrine and Metabolic Advisory Committee meeting tomorrow and it looks like Contrave (bupropion plus naltrexone) will have some challenges facing benefits versus risks and may be required to have followup or additional studies performed.

The hint comes from the documents and questions which have been posted (www.fda.gov) in advance of the meeting and revolve around a 5% standard that the FDA requires as well as some blood pressure and mental status changes that emerged. The challenging situation for the FDA will be to think about the ramifications of asking for additional studies and side effect review as the two medicines in this combination pill are already FDA approved (naltrexone available as Revia and bupropion as Welbutrin). Would this mean that the existing drugs would also have to undertake such studies?

It's actually hard to tell what the decision will be, but it certainly should be an interesting meeting.

members circle The history in the FDA for weight loss medicines recently has been full of questions, rejections and even one removal (Meridia). Why the hard line? Risk to benefit considerations have been paramount since any approved medicine will be probably taken by a large number of people for a long period of time. Recent rejections include Qnexa and Lorqess and safety issues prompted an FDA review of sibutramine (Meridia) which was withdrawn from the market. Once again, it's important for the FDA to review medicines carefully--yet when a new medicine is made of two which are currently on the market, you would think that any FDA decision on the combination pill might effect the two separate ingredients. The meeting tomorrow should be complicated, yet perhaps patients struggling with significant weight issues may have a new treatment. See the agenda and pending questions at www.fda.gov

Long wait for weight loss at the FDA

flowers by vase  Once again, a pharmaceutical company has submitted a weight loss product to the FDA. This one is different though, Contrave is a combination of TWO FDA APPROVED PRODUCTS (bupropion and naltrexone). You may remember two previous products which were rejected partially on safety concerns by the FDA.

This website is not intended as medical advice, and you should consult your doctor before changing or adding any medicines or vitamins to those you may now be taking and about applying any strategies BEFORE you adopt any approach in this report. While diligent care has been taken to ensure the accuracy of the information provided during the preparation of this edition, no claim is made that all known actions, uses or side effects, strategies for cost containment, targets or cholesterol pathways are included in this report. The accuracy and currentness of information are ever subject to change relative to new guidelines, new information derived from drug research, development and general usage.