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news.The FDA has issued an approvable letter for GlaxoSmithKline and Pozen's migraine treatment, Trexima. An approvable letter is an official notification from the FDA that contains conditions that must be satisfied prior to obtaining final US marketing approval.
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The FDA has requested additional safety information on Trexima, which may require new studies. Pozen and GSK said that they intend to request a meeting with the FDA as quickly as possible to discuss the approvable letter and determine the appropriate next steps to gain full approval.
Trexima, the proposed brand name for the product candidate combining sumatriptan 85mg as the succinate salt, formulated with RT Technology and naproxen sodium 500mg in a single tablet, is the first product designed to treat multiple mechanisms of migraine: inflammation and vasodilation.
Sumatriptan succinate is the active ingredient in GSK's already marketed migraine treatment Imitrex. Naproxen sodium is a non-steroidal anti-inflammatory drug (NSAID) and is contained in a number of already approved drugs.