By COLLEEN CREAMER
For VerusMed
AstraZeneca Plc and Pozen Inc.’s investigational drug PN 400 (esomeprazole/naproxen) achieved its primary endpoint of reducing gastric ulcers in two Phase III trials, data from the trials reveal.
PN 400–a combination of an immediate-release version of 20 mg esomeprazole, the active ingredient in AstraZeneca’s Nexium, and enteric-coated naproxen 500 mg–is being developed for the treatment of patients who need chronic nonsteroidal anti-inflammatory drug (NSAID) therapy for arthritis pain and who may be at risk for developing NSAID-associated gastric ulcers.
In both trials, known as PN 400-301/302, approximately 400 participants were randomized to receive PN 400 or enteric-coated naproxen 500 mg twice daily for six months. The participants underwent upper endoscopy at baseline and at one, three and six months. The primary endpoint was the cumulative incidence of gastric ulcers as confirmed by endoscopy.
Results of the studies revealed that those who took PN 400 experienced statistically significantly fewer endoscopically confirmed gastric ulcers as compared with those who received naproxen.
The appropriateness of the studies’ primary endpoints is currently under review by the Food and Drug Administration, and an internal FDA meeting is planned for the first quarter of 2009 to discuss the issue.
Pozen and AstraZeneca entered into a co-development agreement for PN 400 in 2006. The New Drug Application for PN 400 is planned for the middle of next year.
