Medication Monitor

Generic Name (Trade Name—Company)
August 29, 2011


(Nucynta ER—Janssen Pharmaceuticals)
Extended-release formulation


Treatment of moderate-to-severe chronic pain

Janssen Pharmaceuticals announced the FDA approval of extended-release tapentadol tablets for 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 Schedule II product will be marketed in 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg strengths.

The efficacy of extended-release tapentadol was proven in various studies, including trials of patients with moderate-to-severe chronic low back pain and those with pain of diabetic peripheral neuropathy. The most common (≥10%) adverse reactions with this formulation were nausea, constipation, headache, dizziness, and somnolence.

The product was approved with a Risk Evaluation and Mitigation Strategy to educate prescribers about the potential for abuse, misuse, overdose, and addiction from use of this opioid product.