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 | | CENTRALLY ACTING ANALGESIC TAPENTADOL - LATEST PHASE II DATA FOR THE TREATMENT OF ACUTE POSTOPERATIVE PAIN PRESENTED | | | Gruenenthal GmbH | | 01/10/2007 | | | AACHEN, Germany - At this year's 4th World Congress of the World Institute of Pain (WIP), the German pharmaceutical company Grunenthal GmbH presented the latest clinical data on its centrally active analgesic tapentadol in acute pain. Tapentadol combines two analgesic principles in one molecule, Mu-receptor agonism and noradrenaline reuptake inhibition, and appears to be well suited for acute as well as chronic pain conditions.
After promising results in early clinical trials with single-dose administration of tapentadol(1), the latest Phase II data show the efficacy and safety of tapentadol in multiple dose studies. An immediate release (IR) formulation of tapentadol was tested for the treatment of acute post-surgical pain following bunionectomy, a standard foot surgery(2). The predictable level of moderate-to-severe pain for several days make bunionectomy an excellent model for assessing the efficacy of potent analgesics(3),(4).
Efficacy
268 patients were included in the study and assigned to one of four treatment groups. Patients received an oral dose of either tapentadol IR 50 mg, tapentadol IR 100 mg, oxycodone HCl IR 10 mg, or placebo every 4 to 6 hours over three days.
The results demonstrate that tapentadol IR 50 mg and 100 mg are effective for the relief of moderate-to-severe pain: both doses showed a significant improvement in pain relief compared to placebo (tapentadol IR 50 mg p=0.0133; tapentadol IR 100 mg p=0.0001), as did the active comparator oxycodone (p=0.0365).
Tolerability
The data suggest that tapentadol exerts an improved tolerability profile, especially in regard to gastrointestinal side effects like nausea, vomiting and constipation, compared to oxycodone at equieffective dosages. Tapentadol IR 50 mg as well as tapentadol IR 100 mg was associated with an incidence of constipation that was less than half than associated with oxycodone IR 10 mg (6.0% and 7.4% versus 17.9%, respectively).
"There is a high medical need for pain medication with the efficacy of strong centrally acting analgesics, but with an improved tolerability profile", says Prof. Dr. Eric-Paul Pâques, member of the Executive Board of Grunenthal. "With its combined mode of action tapentadol is a promising novel treatment approach for both patients with acute or chronic pain".
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. The companies currently are conducting a phase III developmental program for tapentadol for acute and chronic pain conditions. | |
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