Design of Pozen studies under scrutiny by FDA

The US Food and Drug Administration has told Pozen it is conducting an internal review on the acceptability of endoscopic gastric ulcers as a primary endpoint in clinical studies. The move could potentially affect drug candidates the US drug company is developing with Anglo-Swedish drug major AstraZeneca.

Pozen has been advised by the FDA that an internal meeting could take place on this matter as soon as the agency can gather all the interested parties together, but it did not expect that to happen until the first quarter of next year. The agency began the review as part of ongoing discussions with the US company and the review of both the Special Protocol Assessment for PA32540 and the Statistical Analysis Plan for PN 400.

Two years ago (Marketletter September 11, 2006), Pozen signed an exclusive collaboration deal with AstraZeneca to develop proprietary fixed-dose combinations of the proton pump inhibitor esomeprazole with the non-steroidal anti-inflammatory drug naproxen for the management of chronic pain and inflammation.