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Phase II Data Show Efficacy and Tolerability of Tapentadol in Chronic Pain Treatment

intensity compared to patients in the placebo group (p=0.021). When both dose groups of tapentadol were compared to the oxycodone arm of the study (added as sensitivity control of the model), tapentadol ER 100 mg bid was found to be similar to oxycodone HCl CR 20 mg bid, providing further support that the analgesic efficacy of tapentadol is in the range of other strong centrally acting analgesics.

Safety and Tolerability - In general, the most common adverse events in all groups were typical for a treatment with centrally acting analgesics. With respect to gastrointestinal (e.g. nausea, vomiting, constipation) and CNS (e.g.

somnolence, dizziness) side effects, the data suggest an improved tolerability of tapentadol compared to oxycodone. The incidence of constipation with both tapentadol ER 100 mg (7%) and 200 mg (10%) was less than or equal to half of the incidence associated with oxycodone CR 20 mg (20%).

Tapentadol Co-Development Partnership - Tapentadol is the latest innovation coming out of Grunenthal's R&D pipeline. Grunenthal and Ortho-McNeil Pharmaceutical, Inc, based in Raritan, NJ, United States, began working together on tapentadol in 2003 with a licensing agreement for the United States and Canada. The companies are co-developing tapentadol in the United States, Canada, and the European Union. In January 2007, Grunenthal announced the extension of the licensing agreement with Ortho-McNeil Pharmaceutical to include the Japanese market.

About Grunenthal - Grunenthal is an expert in pain therapy and gynaecology and a pioneer in intelligent, user-friendly drug delivery technologies. The company discovers, develops, produces and markets high therapeutic value pharmaceuticals that contribute to patients' ability to control their own lives. Grunenthal is an independent, family-owned German company operating with affiliates in 27 countries all over the world. Founded in 1946, t
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