(NASDAQ.com) — The Food and Drug Administration said Contrave, a proposed weight-loss drug from Orexigen Therapeutics Inc. (OREX), raised blood pressure in some patients but met one of the agency’s standards for being an effective weight-loss treatment.
Contrave, which is being developed with Takeda Pharmaceutical Co. (TKPYY, 4502.TO), is a combination of two drugs already on the market, antidepressant bupropion and addiction-treating naltrexone. The product will be reviewed next week by an FDA advisory panel. A review of Contrave was posted on the agency’s website Friday in preparation for the meeting.
The FDA said there were more adverse events related to hypertension, or high blood pressure, in the Contrave group compared to placebo, particularly in the study conducted done in patients with type 2 diabetes. The agency also said Contrave “attenuates or eliminates the blood pressure and pulse reductions that are normally seen with weight loss,” which has an unknown impact on cardiovascular risk over the long-term.
The FDA panel will be asked whether an additional clinical study “designed to examine the drug’s effect on risk for major adverse cardiac events should be conducted” before the product is approved or whether it could be conducted in a post-market setting.
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