June 22, 2018
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Pfizer, Acura say FDA clears new painkiller Oxecta

By Associated Press, Special to the BDN



NEW YORK — Pfizer Inc. and Acura Pharmaceuticals Inc. said Monday 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 moderate to severe pain. The drug is designed to discourage common methods of abuse like crushing or dissolving, and it contains a compound that irritates the nose if it is snorted.

Shares of Acura, based in Palatine, Ill., rose 78 cents, or 20.2 percent, to $4.65 in afternoon trading. Earlier in the day its shares surged as much as 75.7 percent. Pfizer stock was unchanged at $20.26.

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.

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