Johnson & Johnson and its subsidiaries, PriCara and Ortho-McNeil-Janssen, announced that they have submitted a New Drug Application (NDA) to the FDA for tapentadol extended release (ER) tablets for the management of moderate to severe chronic pain in patients ≥18 years of age. The submission includes results from a number of 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.
Tapentadol ER is an investigational, centrally acting oral analgesic that binds to mu-opioid receptors and inhibits norepinephrine re-uptake. The tapentadol ER tablet formulation is designed to provide a high degree of mechanical resistance, such as to crushing or chewing. Nucynta, a Schedule II, immediate release tapentadol tablet, is already approved by the FDA for the relief of moderate to severe acute pain in patients ≥18 years of age.
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