FDA seeks more data on J&J pain treatment

By Reuters
Posted Oct. 4, 2010 at 10:14 a.m.

U.S. health regulators have requested more data on Johnson & Johnson’s chronic pain treatment before they will approved the product, the company said Monday.

The Food and Drug Administration sent J&J a complete response letter for J&J’s tapentadol extended release tablets.

The agency is seeking data regarding the conversion of the extended release formulation to a different formulation designed to increase resistance to breaking or crushing, J&J said. Drug abusers often seek to crush pain medicines to make them easier to snort or inject.

The FDA has not requested new clinical studies evaluating the product’s efficacy or safety, J&J said.

J&J, whose consumer medicines unit has been beset by product recalls the last year, is seeking approval to market tapentadol extended release as an oral analgesic for the management of moderate to severe chronic pain in patients 18 and older.

The product is an extended release version of J&J’s acute pain treatment Nucynta, for which J&J won U.S. approval in November 2008.

J&J shares were off 4 cents, at $61.71, in morning trading on the New York Stock Exchange.

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