The Food and Drug Administration has approved Janssen Pharmaceuticals Inc.'s Topamax for the prevention of migraine headaches in adolescents ages 12 to 17.


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Janssen's Topamax OK'd as migraine treatment for adolescents

March 31st, 2014

WASHINGTON – The Food and Drug Administration has approved Janssen Pharmaceuticals Inc.'s Topamax for the prevention of migraine headaches in adolescents ages 12 to 17.

The FDA said Friday that Topamax (topiramate) is the first medication that it has approved for migraine treatment in that age group. The medicine is taken on a daily basis to reduce the frequency of migraine headaches.

Topamax was approved for migraine prevention in adults in 2004. The drug was first approved by the FDA in 1996 to prevent seizures.

The safety and effectiveness of Topamax in preventing migraine headaches in adolescents ages 12 to 17 was established in a clinical trial that enrolled 103 participants, according to the FDA. Those treated with Topamax experienced a decrease in the frequency of migraine of about 72%, compared with 44% in participants that took a placebo. Topamax must be dispensed with a medication guide that describes important safety information about the drug.

About 12% of the U.S. population experiences migraine headaches, the FDA reported.

"Migraine headaches can impact school performance, social interactions and family life," stated Eric Bastings, M.D., deputy director of the division of neurology products in the FDA's Center for Drug Evaluation and Research. "Adding dosing and safety information for the adolescent age group to the drug's prescribing information will help to inform health care professionals and patients in making treatment choices."

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