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J&J pain drug delayed

Johnson & Johnson has been informed that additional information for its extended-release tapentadol is needed before US approval

The US Food and Drug Administration (FDA) has informed Johnson & Johnson Pharmaceutical Research & Development (J&JPRD) that additional information is needed before the federal agency can act on the company's New Drug Application (NDA) for extended-release tapentadol. The drug is being reviewed for the management of moderate to severe chronic pain in adults.

The company said that the Complete Response Letter issued by the FDA seeks additional information on the conversion of the formulation of the drug used in the clinical trials to a different formulation that is intended to reduce the potential for abuse by making the tablet harder to break or crush. The FDA is not requesting additional clinical studies, J&JPRD noted.

"We will engage FDA in active discussions as quickly as possible so that we can address the requests in the Complete Response Letter," Juergen Haeussler, therapeutic area head, analgesia, at J&JPRD, said in a written statement. "We remain fully committed to bringing tapentadol ER to patients experiencing chronic pain as quickly as possible."

The drug is a long-acting version of the company's Nucynta pain therapy, which was approved by the FDA in late 2008 and is marketed in the US by the PriCara division of J&J's Ortho-McNeil-Janssen Pharmaceuticals. J&JPRD submitted the NDA for the extended-release formulation on December 1, 2009 on behalf of Ortho-McNeil-Janssen, which will market the extended-release product if it is approved.


4th October 2010


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