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FDA Approves Opioid Analgesic for Chronic Pain

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Janssen Pharmaceuticals in Raritan, New Jersey says the Food and Drug Administration has approved its drug Nucynta ER for the management of moderate to severe chronic pain in adults. The company is a division of drug manufacturer Johnson & Johnson.

Nucynta ER is an oral analgesic taken twice daily, and prescribed when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. It is available in strengths of 50 to 250 mg. The drug’s active ingredient, tapentadol, is considered a Schedule II controlled substance, with a high potential for abuse and may lead to psychological or physical dependence.

Johnson & Johnson and Grünenthal GmbH in Aachen, Germany, conducted phase 3 clinical studies that tested the efficacy and safety of Nucynta for the treatment of moderate to severe chronic low back pain and painful diabetic peripheral neuropathy. The drug’s safety was also evaluated in more than 1,100 patients with moderate to severe chronic pain over a one-year period.

Janssen says it has developed a Risk Evaluation and Mitigation Strategy for the medication, in collaboration with the FDA. This strategy, similar to those developed for other medicines in this category, educates prescribers about the potential for abuse, misuse, overdose, and addiction from exposure to Nucynta.

Read more: New Initiative to Speed Pain Treatments

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