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news.Grunenthal has reported that a new drug application has been submitted to the FDA for tapentadol immediate release tablets by its co-development partner Johnson & Johnson Pharmaceutical Research & Development.
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Data from clinical Phase II and Phase III trials indicate that tapentadol has efficacy comparable to strong, centrally acting analgesics like oxycodone and morphine, whilst offering and at the same time an improved tolerability profile, especially with regard to nausea, vomiting and constipation.
Data was also submitted to FDA from an additional double blind Phase III study that supported the safety and tolerability of multiple doses of tapentadol IR versus oxycodone IR in the treatment of outpatients with low back pain or pain from osteoarthritis of the hip or the knee over a period of 90 days. More than 1,800 patients have been treated with tapentadol in the clinical development program of the immediate release formulation.
In the EU, tapentadol is currently in Phase III of the development program for severe acute pain, and the company plans to submit it for approval later in 2008.