J&JPRD receives FDA Complete Response Letter for tapentadol ER tablets NDA

Oct 4 2010

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for tapentadol extended release tablets.  The application, filed by J&JPRD in late 2009 [see press release at  http://www.jnj.com/connect/news/product/20091201_200000], seeks 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 FDA has not requested any new clinical studies evaluating the efficacy or safety of tapentadol extended release.  The agency is, however, requesting data regarding the conversion of the extended release formulation used in the clinical efficacy and safety trials to a different extended release formulation that is designed to increase mechanical resistance to breaking or crushing.

"We will engage FDA in active discussions as quickly as possible so that we can address the requests in the Complete Response letter," said Juergen Haeussler, MD, Therapeutic Area Head, Analgesia, J&JPRD.  "We remain fully committed to bringing tapentadol ER to patients experiencing chronic pain as quickly as possible."

The NDA filing is part of the ongoing commitment of J&JPRD to bring new and innovative products to patients and physicians for the treatment and management of pain.