J&J Gets Complete Response Letter for Nucynta ER NDA

Johnson & Johnson (J&J) will have to provide more information to the FDA regarding a formulation change for its pain drug Nucynta ER to gain approval, according to a complete response letter. The letter is in response to J&J’s NDA to market Nucynta ER (tapentadol extended-release) as a treatment for moderate-to-severe chronic pain in adults. Although no new clinical studies were requested, the agency is seeking data on a change to the formulation, made during clinical trials, to curb abuse through greater resistance to breaking or crushing of the tablet.
Washington Drug Letter