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

The German pharmaceutical company Grunenthal GmbH presented the first clinical evidence for the efficacy and tolerability of tapentadol ER (extended release) for patients suffering from chronic pain at the Annual Congress of the European League Against Rheumatism (EULAR), 13-16 June 2007, Barcelona, Spain. Tapentadol, a centrally acting analgesic, is the first of its kind, combining two analgesic principles, mu-receptor agonism and noradrenaline reuptake inhibition, in one molecule.

The new study results show that tapentadol ER is effective for at least 4 weeks in the treatment of moderate-to-severe chronic pain due to osteoarthritis of the knee(1).

The broad analgesic efficacy of tapentadol derived from preclinical models has previously been confirmed for acute pain conditions in a number of clinical studies(2).

In line with the acute pain data the current findings confirm tapentadol's improved tolerability compared to other strong centrally acting analgesics like oxycodone, and morphine.

"With currently available centrally acting analgesics, many patients are forced to terminate their treatment due to intolerable side-effects", comments Prof. Dr. Eric Paul Pques, member of the Executive Board of Grunenthal. "Our goal is to provide new treatment approaches with strong analgesic efficacy and improved tolerability to these patients. The promising results with tapentadol show that we are on the right track".

Efficacy A total of 670 patients were included in this clinical trial, with a primary objective of evaluating the safety and efficacy at the end of 4 weeks of treatment with tapentadol. Subjects in this study underwent a titration period, and were subsequently treated with a fixed dose of either tapentadol ER 100 mg, 200 mg, oxycodone HCl CR 20 mg, or placebo, all bid (twice daily).

Patients who received tapentadol ER 200 mg bid experienced a significant improvement in pain 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 he company employs 1,900 people in Germany and 4,800 worldwide. In 2006, Grunenthal achieved revenues of 813 million Euro.


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