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news.Johnson & Johnson Pharmaceutical, together with Ortho-McNeil Pharmaceutical, is to initiate phase III studies of tapentadol in moderate-to-severe acute pain in the third quarter of 2006.
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Tapentadol (CG5503/ R331333) is a novel, centrally acting analgesic with a dual mechanism of action developed by German pharmaceutical company Grunenthal.
Ortho-McNeil Pharmaceutical entered into a licensing agreement for tapentadol in February 2003. Under the agreement, Johnson & Johnson is co-developing the product with Grunenthal. The initiation of phase III studies will trigger an undisclosed payment to Grunenthal.
If successfully developed, tapentadol would be the first new molecular entity to enter medical practice in the oral opioid category in over 25 years. Preclinical and early clinical data evaluating tapentadol will be presented at the upcoming American Pain Society meeting.