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FDA Considers Treximet for Adolescents With Migraine

In potential good news for adolescents living with migraine disease, the U.S. Food and Drug Administration has accepted a supplemental New Drug Application (sNDA) for Treximet, a combination medication containing sumatriptan and naproxen sodium.

With the agency’s approval, Treximet would become the first sumatriptan or combination prescription medication for the treatment of acute migraine attacks with or without aura for ages 12 to 17. Currently, Treximet is approved only for acute migraine treatment in adults.

Treximet manufacturer, Pernix Therapeutics, based in Morristown, New Jersey, has indicated it expects FDA approval in the second quarter of this year.

Doug Drysdale, the company’s chief executive officer, noted that Pernix is pleased to be moving ahead with the FDA approval process.

“We believe that Treximet has the potential to make a meaningful difference in the lives of adolescent migraine patients, and we look forward to continuing to work with the FDA in its review of the Treximet sNDA,” he said in a company press release.

Arthur Elkind, MD, the President of NHF, noted that Axert (almotriptan) received approval from the FDA in 2008 for adolescent migraineurs. However, the approval was stated with a reservation regarding its effectiveness in that age group.

“The treatment of adolescents with pharmaceutical agents and FDA approval has encountered difficulty due to the nature of adolescent migraine, which is frequently of short duration and can reduce the statistical evidence of drug efficacy as compared to placebos,” he added.

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