Johnson & Johnson Pharmaceutical Research & Development, L.L.C. has submitted a New Drug Application (NDA) to the 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.
Data from these studies provide evidence that tapentadol ER has efficacy to reduce moderate to severe chronic pain compared to placebo. The data also provide evidence of long-term safety and tolerability of tapentadol ER.
The tapentadol ER tablet formulation is designed to provide a high degree of mechanical resistance, such as to crushing or chewing.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., (J&JPRD) is conducting the clinical program for tapentadol in the United States. J&JPRD submitted the NDA for tapentadol on behalf of Ortho-McNeil-Janssen Pharmaceuticals, Inc., an affiliated company that will hold the NDA for tapentadol. Upon FDA approval, PriCara,® Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., will market tapentadol ER in the United States.