Pozen, Glaxo may conduct more studies of investigational migraine treatment Trexima

By Elaine Rigoli

Tampa, Fla., June 9 - The Food and Drug Administration sent an approvable letter for Trexima to Pozen, Inc. and GlaxoSmithKline, which contains conditions that must be satisfied prior to obtaining final U.S. marketing approval.

Although the FDA has determined that Trexima is effective as an acute treatment for migraine headaches, the FDA has requested additional safety information on Trexima, which may require new studies.

Trexima, the proposed brand name for the product candidate combining sumatriptan 85 mg, as the succinate salt, formulated with RT Technology and naproxen sodium 500 mg in a single tablet, is designed to treat multiple mechanisms of migraine: inflammation and vasodilation.

GlaxoSmithKline is a pharmaceutical and health care company with headquarters in London.

Pozen is a pharmaceutical company located in Chapel Hill, N.C.

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