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news.Pozen, a pharmaceutical company, has announced positive Phase III trial results for its PN 400 product candidate conducted by the company under an agreed special protocol assessment with the FDA.
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According to the company, both the PN 400-301/302 studies achieved the primary endpoints. Subjects taking PN 400 experienced statistically significantly fewer endoscopically confirmed gastric ulcers on PN 400 compared to subjects receiving enteric coated naproxen during the six-month period.
In each of the trials, approximately 400 subjects received either PN 400 or enteric coated naproxen 500mg, twice daily, over a six-month treatment period. Subjects underwent upper endoscopies at baseline and at one, three, and six months with the primary endpoint as the cumulative incidence of gastric ulcers.
The FDA has recently informed Pozen that the appropriateness of this endpoint is the subject of an internal review and an FDA internal meeting is planned in third quarter of 2009 to discuss this matter.
Pozen and AstraZeneca entered into a co-development agreement for PN 400 in August 2006. PN 400 is an investigational product under clinical development in patients who require chronic non-steroidal anti-inflammation drug (NSAID) treatment for arthritis pain, such as osteoarthritis and who are at risk for developing NSAID-associated gastric ulcers. The new drug application submission is planned for mid-2009.