(Corrects topiramate spelling in story published May 17.)
Vivus Inc. (VVUS) said its effort to win regulatory approval for weight-loss pill Qnexa may be helped by a study showing little risk of birth defects in children of women who took one of the medicine’s ingredients.
The study, published today in the Journal of the American Medical Association, reviewed the outcomes of about 838,000 births in Denmark from 1996 to 2008 and found that new anti- epileptic drugs including topiramate, one of the two medications that combine to form Qnexa, didn’t significantly increase birth defects. Topiramate is used to control seizures and migraine headaches and marketed by Johnson & Johnson (JNJ) as Topamax.
The U.S. Food and Drug Administration declined on Oct. 28 to approve Qnexa, citing concerns it may cause birth defects and increase heart rate. Vivus is now conducting a trial using information in available databases to evaluate children whose pregnant mothers took topiramate. The Danish results are encouraging, said Peter Tam, president of the Mountain View, California-based company.
“This is really the first population-based study reporting on the risk” from the anti-epileptic treatments that entered the market in the late 1990s and early 2000s, Tam said today in a telephone interview. “The author found that none of these drugs including topiramate were shown to cause major birth defects when taken during the first trimester.”
If the analysis now being conducted by Vivus reaches similar conclusions, the company may be able to market the drug to all obese and overweight people without warning women of child-bearing age not to take it, Tam said. About 28 million of the 108 million adults potentially eligible for the medication are women who might become pregnant. Women who know they’re pregnant will be advised not to take the drug in any case just to be safe, Tam said.
Qnexa combines topiramate with the appetite suppressant phentermine.
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