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J&J Wins U.S. FDA Approval for Long-Acting Version of Pain Pill

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Aug. 26 (Bloomberg) -- Johnson & Johnson won U.S. clearance to sell an extended-release version of the Nucynta pain drug.

The Food and Drug Administration approved the twice-daily pill, also known as tapentadol, to treat chronic pain in adults, the company said today in a statement. The therapy, an opiate, has crush-resistant properties to deter abuse.

The shorter-acting version of New Brunswick, New Jersey-based J&J’s drug gained FDA approval in November 2008 for acute pain. The Drug Enforcement Administration classifies Nucynta as a schedule II controlled substance, meaning distribution is restricted because of a high potential for abuse. Sales of Nucynta may reach $262 million next year, according to the average estimate of two analysts surveyed by Bloomberg.

J&J, the world’s second-biggest maker of health products, said in October that the extended-release version had failed to win approval because the FDA wanted more information about the drug’s tamper-resistant formulation. The company submitted the additional data in February.

To contact the reporter on this story: Molly Peterson in Washington at mpeterson9@bloomberg.net

To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net

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