Pozen Inc, announced positive phase-3 trial results for its PN 400 product candidate (enteric coated naproxen 500 mg and immediate release esomeprazole 20 mg) conducted by Pozen under an agreed Special Protocol Assessment with the FDA.
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 500 mg, 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 Q1 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 NDA submission is planned for mid-2009. Full results of the PN 400 phase-3 studies will be published in a timely manner.
Osteoarthritis is one of the most frequent causes of physical disability among adults. An estimated 46 million adults in the US have physician diagnosed arthritis, accounting for 21 per cent of the US adult population, and two thirds of the people that have doctor-diagnosed arthritis are under the age of 65. Fifty percent of people on chronic NSAID's are at risk for developing NSAID-associated gastric ulcers.
Pozen is a pharmaceutical company committed to developing therapeutic advancements for diseases with unmet medical needs where it can improve efficacy, safety, and/or patient convenience.