Weight-loss Drug ‘Benign’ to be Reviewed by FDA

Posted in Health Tips

Jul 14, 10 Weight-loss Drug ‘Benign’ to be Reviewed by FDA

In Nasdaq, trading shares of Vivus Inc. rose after an authoritarian review of its weight-loss pill Onexa was not as burdensome as many investors expected.  Manufacturers of rival treatments also saw their stock rise.

A mixture of the appetite suppressant phentermine and the anticonvulsant topirimate, is the Vivus Onexa that may basis birth deficiencies and a “low” level of psychiatric side effects, Food and Drug Administration staff said. The report recommends that security worries won’t stall endorsement for Qnexa, the first instruction diet drug in more than a decade, according to Leerink Swann & Co. analyst Steve Yoo.

“The tenor of the FDA appears fairly benign,” Yoo said “They’re not beating away at the company.”

An FDA advisory panel will meet Thursday to discuss whether Qnexa should be approved. An evaluation for Arena Pharmaceuticals Inc.’s lorcaserin is scheduled for Sept. 16, go behind by Orexigen Therapeutics Inc.’s Contrave on Dec. 7. While the agency frequently follows the panel proposals, it isn’t necessary to do so.

The FDA reviewers said that people on Qnexa lost as much as 8.9 percent additional weight than those taking placebo in two studies. Medical weight-management products should assist people lose at least 5 percent more weight than a placebo after a year, as per 2007 agency proposals.

The evaluation focal point mainly on the drug’s safety, particularly the probable for birth defects, psychiatric and cognitive side effects, and excess acid production called metabolic acidosis and danger on cardiovascular.

The causes of birth defects in animals are the high doses of topirimate.  whereas the FDA found it “supportive” that no problems were seen in 13 babies born to women taking Qnexa in studies, data are “much too limited” to rule out a risk, said Eric Colman, deputy director of the agency’s Division of Metabolism and Endocrinology Products. The FDA proposed a contraindication for use during pregnancy and a caution to women of giving birth of a child.