Nucynta ER (tapentadol extended release) was approved by the U.S. FDA on August 26, 2011 for the management of chronic pain. Nucynta ER is an oral analgesic to be taken twice daily for the management of moderate to severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is indicated for an extended period of time. The approval of Nucynta ER is based on a phase III clinical trial that evaluated the drug as a treatment for moderate to severe low back pain and diabetic peripheral neuropathy. The drug's safety was evaluated in 1,100 patients with moderate to severe chronic pain over a one-year period.
In 2008, the FDA approved Nucynta (not the extended release version) for the relief of moderate to severe acute pain. In 2010, a study that compared tapentadol to oxycodone in knee osteoarthritis patients found tapentadol was effective for pain relief with fewer gastrointestinal side effects than oxycodone.
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