FDA aprroves a new pain drug

Shares of Pozen Inc. surged more than 21% in the after hours trading session Friday after the U.S. Food and Drug Administration or FDA approved VIMOVO delayed-release tablets for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.

VIMOVO, co-developed by Pozen and UK-based drug maker AstraZeneca Plc is a fixed-dose combination of enteric-coated naproxen, a pain-relieving non-steroidal anti-inflammatory drug or NSAID, and immediate-release esomeprazole, a proton pump inhibitor or PPI.

The FDA approval was supported by data from a clinical development program, including results from the pivotal PN400-301 and PN400-302 studies, which showed patients taking VIMOVO experienced significantly fewer endoscopic gastric ulcers, compared to patients receiving enteric-coated naproxen.

Nearly 27 million US residents and 140 million people worldwide suffer from osteoarthritis, which is the most common form of arthritis. According to the company, half of osteoarthritis patients on chronic non-steroidal anti-inflammatory drugs therapy are at the risk of developing gastric ulcers associated with it.

Howard Hutchinson, M.D., Chief Medical Officer, AstraZeneca, said, “In a single pill, VIMOVO provides a proven pain reliever with a built-in PPI for arthritis patients at-risk for NSAID-associated gastric ulcers.”

In the PN400-301 and 302 studies, the primary end point was the cumulative incidence of gastric ulcers through six months. Patients received either VIMOVO or enteric-coated naproxen 500 mg, twice daily, in each of the trial, over a six-month treatment period.

Data from study PN400-301 showed a 4.1% incidence of gastric ulcers in patients taking VIMOVO, compared to 23.1% among patients taking enteric-coated naproxen. Study PN400-302 showed a 7.1% incidence of gastric ulcers among patients taking VIMOVO, compared to 24.3% with enteric-coated naproxen.