Pozen Inc. (POZN), a pharmaceutical company, said Monday that the U.S. Food and Drug Administration or FDA has accepted the New Drug Application or NDA for Vimovo or enteric-coated naproxen / immediate release esomeprazole magnesium, formerly known as PN 400.
Vimovo is a fixed-dose combination of enteric-coated naproxen, a pain-relieving non-steroidal anti-inflammatory drug and immediate release esomeprazole, a proton pump inhibitor. It is under investigation for the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients who are at risk of developing gastric ulcers associated with non-steroidal anti-inflammatory drug.
Nearly 27 million US residents and 140 million people worldwide suffer from osteoarthritis, which is commonly treated with non-steroidal anti-inflammatory drugs. 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.
Only a quarter of osteoarthritis patients on non-steroidal anti-inflammatory drugs are prescribed the gastroprotective agent therapy they need, and up to 60% of patients will not adhere to the recommended proton pump inhibitor co-therapy after the third prescription of non-steroidal anti-inflammatory drug, which makes Vimovo a potentially important treatment option, Pozen said.
As per an agreement between Pozen and drug maker AstraZeneca (AZN), the FDA's notification of acceptance of the NDA filing for Vimovo prompts a $10 million milestone payment from AstraZeneca to Pozen.
POZN closed Friday's regular trade at $6.47, down from the previous close of $6.58, on 50,400 shares.
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