Grunenthal announces new phase III tapentadol results

Pharmaceutical Company Product News

Grunenthal has announced new results from a phase III clinical study of tapentadol immediate release tablets in patients with severe pain.

The novel centrally-acting analgesic showed improved tolerability and high efficacy compared to classical opioids.

It has two mechanisms of action, combining noradrenaline reuptake inhibition and mu-opioid receptor angonism properties in a single molecule.

Study results were presented at the World Congress on Pain by the International Association for the Study of Pain earlier this month in Glasgow, Scotland.

The company said the trial data suggests a new therapeutic option for the sustainable relief of severe pain, with the drug showing a similar high efficacy compared to oxycodone iR, but with lower incidences of gastrointestinal side effects.

"The use of classical opioid medications challenges both healthcare professionals as well as pain patients," Grunenthal said.

It added tolerability problems due to nausea, vomiting or constipation can result in drug rotation, discontinuation of therapy or a reduction in frequency of intake or dosage.

In June 2008, the company reported study results showing Transtec improves treatment for patients experiencing severe cancer pain.

The firm notes pain in patients in metastatic or advanced stages of the disease has been estimated to be greater than two-thirds of all cases.

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