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Obesity drug resubmitted for approval in women under 55.

Vivus's resubmission of the new drug application for its obesity drug Qnexa (topiramate/phentermine) is for a severely limited patient population that excludes all women under 55 years of age.

The price of the deal the company reached with the Food and Drug Administration in September on a plan for an early new drug application (NDA) resubmission was that it would have to restrict the patient population to exclude women of childbearing age to avoid the risk of birth defects in babies born to women taking the drug.

By eliminating patients who could become pregnant, the company sidestepped the concerns about teratogenicity raised in the FDA's "complete response" letter rejecting initial approval on Oct. 28, 2010, Vivus's Chief Financial Officer Timothy Morris said in an interview.

While the company said that the drug can be used in some 80 million Americans, it will not be able to market the drug to a prime demographic.

Mr. Morris said there will be some exceptions; women under 55 will be able to get a prescription if their doctor believes they do not have childbearing potential.

And the company is looking ahead to expand the indication; Vivus is awaiting the results of FORTRESS, a post hoc analysis that will take a closer look at the effects of topiramate on women who bore children while taking the drug. The results are expected in December, and Virus will submit top-line data to the FDA at that time.

According to the Oct. 17 NDA submission, Qnexa will be indicated for obese patients with a body mass index greater than 30 kg/[m.sup.2] or for overweight patients with a BMI over 27 who do not have childbearing potential and who have at least one comorbidity.

On top of the original data sets, the filing adds 2-year data from the SEQUEL study, which is based on a 1-year extension of a subset of patients who completed the 56-week CONQUER study. The NDA also includes study results from a recent sleep apnea trial to help support the company's claims that Qnexa does not contribute to heart disease or an elevated heart rate. The company is also studying the drug for sleep apnea and diabetes.

Qnexa is a combination of phentermine, an appetite suppressant, and topiramate, a form of Johnson & Johnson's antiseizure medication Topamax. Both components are available as generics. In March, the FDA reclassified topiramate as pregnancy category D because of the drug's potential to cause birth defects, usually cleft lip or palette. Warnings are now included on the labels of all forms of the drug, and doctors are instructed to evaluate whether the benefits are worth the risks when treating a woman of childbearing age. A category D warning means that there is now human evidence of the risk of birth defects, as opposed to the category C warning topiramate previously had, which was supported only by evidence in animal studies.

The FDA told the company that its Endocrinologic and Metabolic Drugs Advisory Committee will host a panel in the first quarter of 2012 to reassess the risks associated with the drug. A panel in July 2010 voted 10-6 against approval of the obesity drug.

This coverage is provided courtesy of "The Pink Sheet." This news organization and "The Pink Sheet" are owned by Elsevier.

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Title Annotation:OBESITY
Comment:Obesity drug resubmitted for approval in women under 55.(OBESITY)
Author:Lamotta, Lisa
Publication:Family Practice News
Geographic Code:1USA
Date:Dec 1, 2011
Words:548
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