Tapentadol Tablets For Moderate To Scute Pain In Over 18s Now Available For Use In The United States

Main Category: Pain / Anesthetics
Article Date: 28 Jun 2009 - 0:00 PDT

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German pain expert company Grünenthal GmbH announces that the new centrally acting analgesic tapentadol is now available in the United States. The drug is indicated for the relief of moderate to severe acute pain in patients 18 years of age and older. Approval was given by the US Food and Drug Administration (FDA) in November 2008 for tapentadol (NUCYNTATM) tablets. With the cooperation of Grünenthal and its marketing partner Ortho-McNeil-Janssen Pharmaceuticals, Inc., the medication can now be prescribed by physicians and other appropriate health care professionals in the United States.

"This first launch of tapentadol which has been discovered by Grünenthal and co-developed with Johnson & Johnson Pharmaceutical Research & Development, L.L.C, is an important step in our endeavour to further improve pain management worldwide", said Dr. Alberto Grua, Head of Palexia Global Division, Global Commercial Operations of Grünenthal. "The US patients are the first to benefit from tapentadol which shows comparable efficacy to strong classical opioids and offers a favourable tolerability profile."

More than 25 million Americans experience acute pain each year as a result of injuries or surgery1, and acute pain is the most common reason people seek medical attention.2

The FDA approval of tapentadol was based on data from clinical studies involving more than 2.100 patients with acute pain. The studies found that tapentadol provided significant relief of moderate to severe acute pain compared to placebo.

In Europe, Grünenthal has submitted the Marketing Authorisation Application for two tablet formulations (tapentadol and tapentadol prolonged-release tablets) to several European authorities in April 2009. Grünenthal is seeking a European indication for the relief of severe acute pain and the management of severe chronic pain requiring centrally acting analgesic therapy in adults 18 years of age and older. Tapentadol is the first new substance in its class for more than 25 years.

About Tapentadol

Tapentadol has been under development for severe chronic pain. In the United States, tapentadol was approved by the Food and Drug Administration on November 20, 2008 for the relief of moderate to severe acute pain in patients 18 years of age or older. On April 30th, 2009 Grünenthal has submitted the Marketing Authorisation Application for tapentadol and tapentadol prolonged release to several European authorities. Grünenthal is also preparing the submission of tapentadol to regulatory authorities in Switzerland, Australia, New Zealand, Singapore, Russia, Ukraine, Saudi Arabia, Mexico, and Venezuela in 2009. Other countries will follow later.

Two Mechanisms of Action

Tapentadol has a unique profile with two mechanisms of action, combining mu-opioid receptor agonism and noradrenaline reuptake inhibition properties in a single molecule. Preclinical studies suggest that both mechanisms contribute to the analgesic effects of tapentadol. Μu-receptor agonists are drugs which act at various levels in the pain pathway, by inhibiting the transmission of the pain signal, the emotional aspect of pain and pain realisation. In addition, the analgesic effect of tapentadol, can be explained by the descending inhibition arising from the noradrenaline reuptake inhibition, a recognized analgesic mechanism.

Tapentadol Partnership

Grünenthal discovered tapentadol. Grünenthal and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) have conducted the Phase IIb and III development programs for tapentadol for acute and chronic pain conditions. Grünenthal licensed exclusive rights to tapentadol to Ortho-McNeil-Janssen Pharmaceuticals, Inc., and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), for the United States, Canada and Japan. PriCara®, a division of Ortho-McNeil-Janssen Pharmaceutical, Inc. will market tapentadol in the United States. Grünenthal holds the rights in Europe and other countries worldwide.

References

1. National Pain Survey (1999). The American Pain Foundation. Conducted for Ortho-McNeil Pharmaceutical

2. Coda BA, Bonica JJ. General considerations of acute pain. In: Loeser JD, Butler SH, Chapman CR, et al, eds. Bonica's Management of Pain. 3rd ed. Baltimore, MD: Lippincott Williams & Wilkins; 2001:222-240.

Source
Grünenthal