Pfizer Inc. and Acura Pharmaceuticals Inc. say the Food and Drug Administration approved a powerful painkiller that is designed to be harder to abuse.
The FDA cleared marketing of Oxecta as a treatment for acute or moderate-to-severe pain. The drug also contains niacin, which causes irritation and flushing if patients take extra doses to get high.
Shares of Acura surged $2.02, or 52.2 percent, to $5.89 in premarket trading.
Acura and King Pharmaceuticals developed Oxecta under the name Acurox. Pfizer later acquired King and changed the name of the drug.
Oxecta is similar to Purdue Pharma LP's OxyContin, the top-selling painkiller in the U.S. Regulators and health officials have pushed hard to get alternatives on the market after reports showed millions of people were abusing OxyContin and other prescription painkillers.