AstraZeneca has announced that its development partner, Pozen has submitted a New Drug Application (NDA) to the FDA, for VIMOVO (PN400) tablets.
PN400 is under investigation for the treatment of the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, in patients who are at risk of developing NSAID-associated ulcers. PN400 is a fixed-dose combination of enteric coated naproxen and immediate release esomeprazole.
The proposed trade name is VIMOVO, and is pending regulatory approval. Upon the FDA’s acceptance of the NDA filing for PN400, a $10 million milestone payment from AstraZeneca will be payable to Pozen.
The NDA submission is based on data from a clinical trials program. The PN400 301/302 studies fully met their primary objective. It showed that subjects taking PN400 experienced significantly fewer endoscopically confirmed gastric ulcers, compared to subjects receiving enteric coated naproxen, the company said.
In each of the trials, approximately 400 subjects received either PN400 or EC naproxen 500mg, twice daily, over a six-month treatment period. Subjects underwent upper endoscopies at baseline and at one, three and six months.