J&JPRD submits an NDA for tapentadol ER tablets

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tapentadol extended release (ER) tablets, an investigational oral analgesic for the management of moderate to severe chronic pain in patients 18 years of age or older.

Chronic pain, defined as pain that persists for long periods of time - usually greater than three months - is a significant medical challenge in the United States. According to the National Institutes of Health (NIH), an estimated 100 million Americans suffer from chronic pain. If undertreated, chronic pain can impair an individual's ability to carry out daily activities.

Tapentadol ER is a novel investigational, centrally acting oral analgesic that binds to mu-opioid receptors and inhibits norepinephrine re-uptake. Although the exact mechanism of action is not known, these two mechanisms, which affect established pain pathways, are thought to be responsible for pain relief with tapentadol.

The submission is based on a full clinical development program for tapentadol ER. The program includes Phase 3 double-blind, randomized, active-and placebo-controlled studies. These clinical trials explored the efficacy and safety of tapentadol ER for the treatment of moderate to severe pain in patients with chronic osteoarthritis and low back pain, as well as in patients with diabetic peripheral neuropathic pain. In addition, a one-year, active-control open-label Phase 3 safety trial also was included.