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Centrally acting analgesic tapentadol - latest phase II data for the treatment of acute postoperative pain presented

Aachen (ots)

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, μ-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.
About WIP
The World Institute of Pain is a worldwide organization which aims
to promote the best practice of pain medicine throughout the world. 
It is an internationally recognized organization that brings together
the most recognized experts in the field of pain management for the 
benefit of patients and the advancement of pain management. 
www.worldinstituteofpain.org
About Grunenthal
Grunenthal is an expert in pain therapy and gynaecology and a 
pioneer in intelligent, user-friendly drug delivery technologies. 
Founded in 1946, the company employs 1,900 people in Germany and 
4,800 worldwide. In 2006, Grunenthal achieved revenues of 813 million
Euro. www.grunenthal.com
References
1. Stegmann JU(1), Engels C(1), Steup A(1), Schwarz HJ(1), 
Desjardins PJ(2), Grond S(3): Tapentadol, a Novel Centrally Acting 
Analgesic with a Dual Mode of Action: Efficacy and Safety in Clinical
Acute Pain Models (Poster presented at the 5th Congress of the 
European Federation of IASP Chapters (EFIC), 2006). (1)Research and 
Development, Grunenthal GmbH, Aachen, Germany; (2)Scirex Corporation,
Austin., Texas, United States; (3)Martin-Luther-University 
Halle-Wittenberg, Halle, Germany.
2. Stegmann JU(1), Weber H(1), Steup A(1), Upmalis D(2), Link 
A(3), Desjardins PJ(3): Efficacy and Tolerability of Tapentadol 
Immediate Release for the Treatment of Acute Pain Following 
Bunionectomy (Poster presented at the 4th World Congress of the World
Institute of Pain, 2007). (1)Research and Development, Grunenthal 
GmbH, Aachen, Germany; (2)Johnson&Johnson Pharmaceutical Research & 
Development, L.L. C., Titusville, New Jersey, United States; 
(3)Scirex Corporation, Austin, Texas, United States.
3.Desjardins PJ, Black PM, Daniels S, Bird SR, Fitzgerald BJ, 
Petruschke RA, Tershakovec A, Chang DJ: Curr Med Res Opin 
2004;20:1523-1537.
4. Thipphawong JB, Babul N, Morishige RJ, Findlay HK, Reber KR, 
Millward GJ, Otulana BA: Anesthesiology 2003; 99:693-700.
Contact:

Contact:

Anke Krueger-Hellwig
Phone: +49 241 569-2858,
Fax: +49 241 569-52858
anke.krueger-hellwig@grunenthal.com
Grunenthal GmbH, 52099 Aachen, Germany
www.grunenthal.com

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