NEW YORK (AP) – Pfizer Inc. and Acura Pharmaceuticals Inc. said the Food and Drug Administration approved a powerful painkiller that is designed to be harder to abuse.
The FDA cleared marketing of Oxecta as an immediate-release 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.
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.
Acura and King Pharmaceuticals developed Oxecta under the name Acurox. Pfizer of New York bought King for $3.6 billion, and Oxecta is the first of King’s drugs to be approved since the deal closed in March. A second approval could come Thursday, as Pfizer is waiting for the FDA to return a decision on the drug candidate Remoxy.
OxyContin is an extended-release painkiller, however, and Citi Investment Research analyst John Boris said those drugs represent a larger market. Boris said annual sales of Oxecta could rise as high as $100 million, but Remoxy sales could reach $500 million a year.
Unlike those drugs, Oxecta is designed to start working right away.
Boris said he does not believe Remoxy will be approved this week, as Pfizer has disclosed a manufacturing issue that could delay approval. Remoxy was developed by Durect Corp. and licensed by Pain Therapeutics Inc. Pfizer now holds a sublicense from Pain Therapeutics.
Date: June 20, 2011
Source: Associated Press
Filed Under: Drug Discovery