POZEN (POZN) Submits New Drug Application to FDA for Marketing Approval of VIMOVO

June 30, 2009 8:04 AM EDT

POZEN Inc. (NASDAQ: POZN) announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the marketing approval of VIMOVO(TM) (PN 400), the combination of enteric coated (EC) naproxen and immediate release esomeprazole. POZEN and AstraZeneca entered into a global co-development agreement for VIMOVO in August 2006. Pending regulatory approval, the proposed trade name is VIMOVO and the proposed indications are for the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients who are at risk for developing NSAID-associated ulcers.

The NDA submission is based on data from a comprehensive clinical trials program. POZEN conducted two pivotal studies (301/302) under a special protocol assessment agreed with the FDA, which met their primary endpoints. In the 301/302 studies, significantly fewer subjects taking VIMOVO experienced endoscopically confirmed gastric ulcers compared to subjects receiving EC naproxen. The primary endpoint was the cumulative incidence of gastric ulcers through six months. In each of the trials, approximately 400 subjects received either VIMOVO or EC naproxen (500 mg), twice daily, over a six-month treatment period. Subjects underwent upper endoscopies at baseline and at one, three, and six months. Upon the FDA's acceptance for filing of the NDA, a $10 million milestone payment from AstraZeneca will be payable to POZEN. [SM]

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