Grunenthal’s new pain treatment approved in US
pharmafile | November 27, 2008 | News story | Sales and Marketing | Grunenthal
The first new oral centrally acting analgesic in more than 25 years has been approved in the US.
Tapentadol was developed by Grunenthal and will be marketed in the US, Canada and Japan by Johnson & Johnson and will treat moderate to severe acute pain.
The drug has been shown to work as well as classical strong opioids (e.g. oxycodone) but has fewer gastro-intestinal side effects such as nausea, vomiting, and constipation.
"Tapentadol represents a great success of the co-operation between Grunenthal and J&J. 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. Paques, member of the executive board of Grunenthal. "Tapentadol is one of several exciting compounds we have in our pipeline."
In the EU, tapentadol is currently in phase III development for other indications, severe acute and chronic pain, and Grunenthal plans the submission in Europe in the second quarter 2009.
Tapentadol is a next generation centrally-acting analgesic, being developed for use as both an immediate-release formulation for acute pain and as a prolonged-release formulation for chronic pain.
The drug 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.
Grunenthal is a family-owned German company which specialises in pain therapy and gynaecology. The company discovered and initiated development of tapentadol until phase II, after which point it forged an development and marketing agreement with J&J.
Grunenthal is preparing the submission of tapentadol IR to regulatory authorities in Europe, Mexico, and South America.
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