ARTICLE | Clinical News

Tapentadol ER regulatory update

October 11, 2010 7:00 AM UTC

FDA issued a complete response letter for an NDA from Johnson & Johnson 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. ...