Nucynta® ER FDA-Approved for Management Of Chronic Pain

August 29, 2011

Nucynta® ER, an extended-release formulation of tapentadol, has received FDA aproval for the management of moderate to severe chronic pain. The oral analgesic, to be taken twice daily, is to be used for chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period.

Nucynta® ER, an extended-release formulation of tapentadol, has received FDA approval for the management of moderate to severe chronic pain. The oral analgesic, to be taken twice daily, is to be used for chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period. The announcement was made by Janssen Pharmaceuticals, Inc, a pharmaceutical company of Johnson & Johnson.

Double-blind, randomized, active- and placebo-controlled phase 3 studies were conducted to evaluate the efficacy and safety of Nucynta® ER for the treatment of patients with moderate to severe chronic low back pain and painful diabetic peripheral neuropathy. In addition, safety was evaluated in more than 1100 patients with moderate to severe chronic pain over a 1-year period. The findings demonstrated efficacy and safety, a favorable tolerability profile, and favorable discontinuation rates, it was noted.

More than 42 million Americans age 20 years and older experience chronic pain, the most common cause of long-term disability, and almost one-third of Americans will experience severe chronic pain at some point in their lives, according to CDC and American Pain Foundation estimates. Although pain treatments are available, additional options are needed to help patients manage their pain appropriately and effectively, according to research published by the American Pain Society. To support the appropriate and effective management of chronic pain, Janssen Pharmaceuticals suggested that supporting educational programs about the safe and responsible use of pain medicines and the prevention of inappropriate use is essential.