FDA approves tapentadol ER for management of moderate-to-severe chronic pain

August 26, 2011

FDA has approved tapentadol extended-release tablets (Nucynta ER, Janssen Pharmaceuticals), an oral analgesic taken twice daily, 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.

FDA has approved tapentadol extended-release tablets (Nucynta ER, Janssen Pharmaceuticals), an oral analgesic taken twice daily, 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.

Although the exact prevalence is unknown, information from the Centers for Disease Control and Prevention and the American Pain Foundation suggests that more than 42 million Americans 20 years of age and over suffer from chronic pain. Chronic pain is the most common cause of long-term disability, and almost one-third of all Americans will experience severe chronic pain at some point in their lives. Yet despite the treatments available, additional treatment options still are needed to help patients manage their pain appropriately and effectively, according to research published by the American Pain Society.

"In clinical trials, Nucynta ER demonstrated proven efficacy for treating moderate-to-severe chronic pain," Paul Chang, MD, vice president, medical affairs, internal medicine, Janssen Pharmaceuticals, said in a company press release. "We are pleased with the FDA's decision to approve Nucynta ER, as it represents an important new option to help people with chronic pain."

Johnson & Johnson Pharmaceutical Research & Development and Grunenthal GmbH, a privately-owned pharmaceutical company based in Aachen, Germany, conducted the double-blind, randomized, active- and/or placebo-controlled phase 3 studies that evaluated the efficacy and safety of Nucynta ER for the treatment of moderate-to severe-chronic low back pain and painful diabetic peripheral neuropathy. In addition, safety also was evaluated in more than 1,100 patients with moderate-to-severe chronic pain over a 1-year period. The findings demonstrate efficacy and safety, a favorable tolerability profile, and favorable discontinuation rates.

Tapentadol is a centrally acting synthetic analgesic. The tapentadol molecule is classified as Schedule II of the Controlled Substances Act.

The most common (≥10%) adverse reactions were nausea, constipation, headache, dizziness, and somnolence.