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news.Johnson & Johnson Pharmaceutical R&D, a wholly owned subsidiary of Johnson & Johnson, has announced that the FDA approved tapentadol immediate-release tablets for the relief of moderate to severe acute pain in adults 18 years of age or older.
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Tapentadol tablets have been approved in 50mg, 75mg and 100mg doses. The approval was based on data from clinical studies involving more than 2,100 patients. The studies showed that tapentadol provided significant relief of moderate to severe acute pain compared to placebo.
Following the FDA approval, and as per federal regulation for all controlled substances, tapentadol will be reviewed by the US Drug Enforcement Agency for scheduling, and it cannot be sold until it receives a scheduling classification. PriCara, a division of Ortho-McNeil-Janssen Pharmaceuticals, will market tapentadol in the US.
Joanne Waldstreicher, global head of R&D for CNS/internal medicine at Johnson & Johnson Pharmaceutical R&D, said: “We are pleased with the FDA’s approval today. Tapentadol represents a new treatment option in pain management, and I am excited that we are able to bring this new choice to patients who are suffering from pain.”