Janssen Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved NUCYNTA ER, 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 age 20 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,” said Paul Chang, M.D., Vice President, Medical Affairs, Internal Medicine, Janssen Pharmaceuticals, Inc. “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, L.L.C. 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.

Additionally, safety also was evaluated in more than 1,100 patients with moderate to severe chronic pain over a one-year period. The findings demonstrate efficacy and safety, a favorable tolerability profile and favorable discontinuation rates.

“Chronic pain is difficult to manage, and even with the treatments available today, it can be a challenge to balance pain relief with a patient’s ability to tolerate the medicine,” said Sunil J. Panchal, M.D., President, National Institute of Pain.* “People with chronic pain will continue to need additional options, so an approval like this is welcome news for this community and the people who suffer from this often debilitating condition.”