Janssen Pharmaceuticals announced that the FDA has approved Nucynta ER (tapentadol extended-release) tablets for the management of moderate-to-severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. This approval was based on data from Phase 3, double-blind, randomized, active- and/or placebo-controlled studies demonstrating efficacy and safety, a favorable tolerability profile and favorable discontinuation rates.
Nucynta ER, a centrally acting synthetic analgesic, is a C-II controlled substance. It is expected to be available the last week of August 2011 in 50mg, 100mg, 150mg, 200mg and 250mg strengths.
For more information call (800) JANSSEN or visit www.janssenpharmaceuticalsinc.com.