FDA Round-Up: New Weight Loss Drug Approved, Polypill Efficacy in Review

The FDA has approved Contrave, a combination of naltrexone hydrochloride and bupropion hydrochloride, for use in patients in need of chronic weight management.

The drug is to be used in combination with reduced-calorie diet and increased physical activity in adults with a body mass index of 30 or greater, or those with BMI over 27 and at least 1 weight-related condition (eg, hypertension, diabetes, or dyslipidemia).
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The efficacy of Contrave was tested in several clinical trials with over 4500 obese and overweight participants. 

Over the course of 1 year, patients without diabetes showed an average weight loss of 4.1% versus placebo. Overall, 42% of participants lost at least 5% of their overall body weight compared with 17% in the control group.

Because it contains bupropion, Contrave may cause suicidal thoughts and seizures.  It can also raise blood pressure and heart rate, and can cause nausea, headache, dizziness, insomnia, and dry mouth.

Reference;

FDA. FDA approves weight-management drug Contrave [press release]. September 10, 2014. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm413896.htm Accessed September 12, 2014. 

Advisory Committee Denies Polypill for Hypertension

In a 2-day series of hearings, the FDA advisory committee failed to approve a new hypertension polypill—a less expensive, patient-friendly, multi-drug combination of beta-blocker and angiotensin receptor blocker.

The advisory panel voted 6 to 4 against approval of the drug (nebivolol and valsartan), citing lacking clinical benefits. Proponents acknowledged these shortcomings but argued that the small effect of the drug, over time, could produce significant benefits.

Following the vote, the committee began a more theoretical discussion of a polypill containing an antihypertensive, aspirin, and a statin.

Proponents argued that the approach would help with patient adherence. The committee addressed 3 issues: efficacy, formulation, and intended population.

No consensus on the drug’s use could be reached.

Reference:

FDA. FDA Briefing document: Cardiovascular and Renal Drugs Advisory Committee

meeting. September 10, 2014. www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/UCM413061.pdf. Accessed September 12, 2014.

—Michael Potts