Pfizer recalls pain drug acquired in King deal

Just weeks after completing its $3.6 billion purchase of King Pharmaceuticals, Pfizer Inc has recalled an opioid painkiller obtained in the deal and said it could remain unavailable for many months because of formulation problems.

Embeda, which has annual sales of less than $70 million, was recalled in the United States because of a stability defect found in the extended-release product during routine testing, according to a notice posted Wednesday on the drug’s website, Embeda.com.

The drug contains pellets of morphine that surround naltrexone, a chemical which blocks opiate effects if the product is crushed or chewed—thereby deterring misuse or abuse.

The naltrexone component was shown to have degraded to unacceptable degrees in samples of Embeda that were tested, Pfizer said. The problem is unlikely to pose a safety risk and patients can continue taking the drug as prescribed, the drugmaker said.

Embeda, approved by U.S. regulators in August 2009, was recalled three times last year due to other formulation problems, all relating to how it dissolves, Pfizer spokeswoman Joan Campion said.

Campion said it remains unclear when Embeda will return to drugstores. “It’s possible it won’t be available for many months.”

The King deal was meant to make Pfizer a significantly bigger player in the pain-drug market by adding King’s pain portfolio to its own treatments, such as Lyrica and Celebrex.

Asked if the recall of Embeda lowers the value to Pfizer of the acquisition, Campion said, “There are other assets that make this a good deal for us. It expands our pain portfolio, both of marketed products and ones in registration,” meaning those awaiting regulatory approvals.

Pfizer last month completed its purchase of King, which had 2009 revenue of almost $1.8 billion. Other King pain drugs acquired in the deal include Avinza, an extended release morphine, and the Flector Patch, whose active ingredient is diclofenac. Pfizer is awaiting regulatory approvals for two other King pain drugs meant to lower the potential of abuse.

The King acquisition also gave Pfizer an array of other King drugs, and an animal health business.

(Reporting by Ransdell Pierson; Editing by Richard Chang)

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(Reuters)