Tapentadol Immediate Release Tablets Approved For The Treatment Of Moderate To Severe Pain By FDA

Main Category: Pain / Anesthetics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 28 Nov 2008 - 0:00 PDT

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Grunenthal GmbH announces that the U.S. Food and Drug Administration (FDA) has approved tapentadol immediate-release tablets for the relief of moderate to severe acute pain for adults 18 years and older. The New Drug Application (NDA) had been submitted to the FDA by Grunenthal's partner for developing and commercializing tapentadol in the USA, Canada, and Japan, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., (J&JPRD), on January 23rd, 2008. Tapentadol is an oral centrally acting analgesic and will be the first new substance in its class for more than 25 years after successful registration. In the European Union, tapentadol is currently in phase III of the development program for severe acute and chronic pain. Grunenthal plans the submission in Europe in the second quarter 2009.

The approval was based on data from clinical studies involving more than 2,100 patients and showed that tapentadol provided significant relief of moderate to severe acute pain compared to placebo.

In addition, the data suggested that treatment with tapentadol for acute moderate to severe pain was associated with a favorable gastrointestinal (GI) side effect profile, compared to oxycodone, a classical opioid and commonly used prescription medication for the treatment of moderate to severe pain.

"Tapentadol represents a great success of the cooperation between Grunenthal and J&JPRD. Tapentadol is a major milestone in Grunenthal's ambition to be one of the world leaders in providing patients suffering from pain with better therapeutic answers" said Prof. Pâques, Member of the Executive Board of Grunenthal. "Tapentadol is one of several exciting compounds we have in our pipeline."

About Tapentadol

Tapentadol is a next generation centrally-acting analgesic which is currently being developed for the relief of severe pain. It demonstrates efficacy comparable to classical strong opioids, like oxycodone, an improved tolerability profile compared to oxycodone in regard to the gastro-intestinal side effects nausea, vomiting, and constipation leading to lower treatment discontinuation rates in clinical studies. Tapentadol is being developed as immediate-release formulation for acute pain and prolonged-release formulation for chronic pain.

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. Mu-receptor agonists are drugs that bind to mu-opioid receptors in the central nervous system. These drugs modify sensory and affective aspects of pain, inhibit the transmission of pain on the spinal cord level and affect activity in parts of the brain that control how pain is perceived. Noradrenaline reuptake inhibitors are a type of central nervous system drugs that increases the level of noradrenaline in the brain by inhibiting its reabsorption into nerve cells; these compounds have analgesic properties.

Grunenthal is preparing the submission of tapentadol IR to regulatory authorities in Europe, Mexico, and South America.

Tapentadol Partnership

Grunenthal discovered and initiated development of tapentadol until phase II. Grunenthal and J&JPRD are conducting the phase IIb and III development programs for tapentadol for acute and chronic pain conditions. Grunenthal licensed rights to tapentadol to Ortho-McNeil-Janssen Pharmaceuticals, Inc., and J&JPRD, for the United States, Canada and Japan. Grunenthal holds the marketing rights in Europe and rest of the world.

About Grunenthal

Grunenthal is an expert in pain therapy and gynaecology and a pioneer in intelligent, user-friendly drug delivery technologies. The company discovers, develops, produces and markets high therapeutic value pharmaceuticals that contribute to patients' ability to control their own lives. Grunenthal is an independent, family-owned German company with companies in 32 countries all over the world. Founded in 1946, the company employs 1,900 people in Germany and 5,300 worldwide. In 2007, Grunenthal achieved revenues of 846 million Euros.

Grunenthal