The Food and Drug Administration accepted the results of a late-stage clinical trial on PN 400, an investigational drug for arthritis treatment made by Pozen Inc. in partnership with AstraZeneca. The news made Pozen’s stock soar, sending its shares up as much as 36 percent.

 

Chief Financial Officer Bill Hodges said, “the acceptance of the filing would fetch us a milestone payment of $10 million.”

 

The FDA said PN 400 met primary endpoint, showing significant fewer gastric ulcers in patients taking the drug, compared to patients given an existing anti-inflammatory drug – naproxen.

 

PN 400 combines naproxen with esomeprazole, a drug developed by AstraZeneca that helps inhibit production of stomach acid. The goal would be a painkiller that is not as harsh on the stomach.

 

Arthritis causes pain and swelling in the joints. Painkillers help sufferers to go on with their daily activities, forgetting about their pain. But, painkillers generally damage the stomach leading to gastritis and ulcers. The new drug appears to decrease this risk, according to the FDA.

 

There are not known causes of arthritis but certain factors such as heredity, overweight, joint injury, repeated overuse of certain joints, lack of physical activity, nerve injury and aging increase the risk of developing the disease. Arthritis and related conditions cost the U.S. economy nearly $128 billion per year in medical care and indirect expenses, including lost wages and productivity.

 

Pozen said it will submit to the FDA a New Drug Application for PN 400 in mid-2009.