FDA Approves New Indication For Pain Drug Nucynta ER Tablets

Janssen Pharmaceuticals Inc. Aug. 29 announced that the Food and Drug Administration has approved Nucynta ER (tapentadol) extended-release tablets for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults.

Janssen said Nucynta ER, an oral analgesic taken twice daily, is the first and only opioid approved by FDA for neuropathic pain associated with DPN. The company submitted the supplemental new drug application for this indication in November 2011 (9 PLIR 1396, 11/4/11).

Nucynta ER already is approved for the management of moderate-to-severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed ...