Chapel Hill drug development company Pozen has won approval from the U.S Food and Drug Administration for Treximet, its migraine pill that is being manufactured in Zebulon by Research Triangle Park giant GlaxoSmithKline.
FDA reviewers asked Pozen to submit additional safety information twice in the past two years, but have finally agreed to permit marketing of the therapy, which combines 85 milligrams of GSK's Imitrex and 500 milligrams of naproxen. Studies have reported the combination relieves migraines more effectively than either ingredient alone.
Treximet becomes Pozen's first marketed product. Besides making the pills, GSK will market Treximet. The drug is expected to replace Imitrex as GSK's blockbuster migraine remedy because Imitrex will lose patent protection in the fourth quarter and face generic competition.
Analysts project Treximet sales to exceed $1 billion a year by 2011. The drug could be on pharmacy shelves later this quarter or in the third quarter.