New York: U.S. health regulators have requested more data on Johnson & Johnson`s chronic pain treatment before they will approved the product, the company said on Monday.
The U.S. 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 that is 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 any 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 past 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 years of age or 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.