Posted at 17:01h
in News to Know
In potential good news for adolescent migraineurs, 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 migraineurs 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.