Pozen seeks FDA approval for pain drug
By
Associated Press
June 30, 2009
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Pozen Inc. said Tuesday it asked the Food and Drug Administration to approve a drug candidate intended to prevent gastric ulcers in patients with chronic pain.
Pozen said it filed a New Drug Application with the FDA, and when the agency receives the application, Pozen will get a $10 million payment from its partner AstraZeneca PLC. The tablets contain a combination of the painkiller naproxen and esomeprazole magnesium, the active pharmaceutical ingredient in heartburn medicine Nexium. The companies proposed the drug be called Vimovo.
The drug is being proposed to treat signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients who are at risk of developing ulcers associated with the use of non-steroid anti-inflammatory drugs.
London-based AstraZeneca and Chapel Hill, N.C.-based Pozen have been developing the drug since 2006. It was previously designated PN400.
Pozen's shares dipped 26 cents to close at $7.68 on Tuesday.
(This version CORRECTS headlines to clarify that drug is a pain treatment)
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