ARTICLE | Company News

FDA wants more data on J&J pain compound

October 4, 2010 11:49 PM UTC

FDA issued a complete response letter for a NDA from Johnson & Johnson (NYSE:JNJ) for tapentadol extended release (ER) tablets to manage moderate to severe chronic pain in adults. J&J said the agency requested data regarding the conversion of the ER formulation used in the clinical efficacy and safety trials to a different formulation that is designed to increase mechanical resistance to breaking or crushing. The company said the agency will not require any new clinical trials. ...