( The German pharmaceutical company Grune...)Phase II Data Show Efficacy and Tolerability of Tapentadol in Chronic Pain Treatment,Health

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
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