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Weight Loss Drug Qnexa Wins Support

Author: Oksana Aron, MD Source: Weight Loss NYC Feb 27, 2012

A new weight loss drug for obese patients may soon come available pending FDA approval.

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The weight loss drug Qnexa was initially rejected by the FDA because of the risk for possible heart problems or birth defects, but an FDA advisory panel recently gave it a recommendation for a full decision come April -- and pushed for a post-approval trial to monitor cardiovascular side effects.

There was concern over the increased risk of an elevated heartbeat and birth defects such as an oral cleft occurring in infants born to women on the drug while pregnant. However, two ingredients in the drug phentermine (an appetite suppressant) and topiramate (which makes you feel full) are already on the market today and can be prescribed off-label.

The drug’s maker, Vivus, is seeking approval for a once-daily pill for obese men and women with a body mass index (BMI) of 30 or higher, or for those with a BMI of 27 or higher who also have weight-related comorbidities such as hypertension, diabetes, dyslipidemia, or central adiposity.

Vivus shared that the drug can help patients lose 6 to 10% of their body weight and it can also lower their blood pressure. The company also worked on a plan with the FDA to do the following as part of a risk mitigation strategy: include labeling that states the drug should be discontinued once a female patient becomes pregnant, distribute it only through mail-order pharmacies that have pharmacists with specific training on the drug, educating providers and patients on contraception and monthly pregnancy testing, and developing a pregnancy registry to keep track of patients.

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Source: MedPageToday.com

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