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news.Adolor Corporation has submitted an investigational new drug application with the FDA for ADL5859, an oral compound for the management of pain. If the application to the FDA is successful the company will be able to begin clinical testing of the compound.
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ADL5859 is a selective novel Delta agonist that has shown activity and an attractive safety profile in preclinical evaluation. The compound is under development for the potential relief of inflammatory and neuropathic pain. There are currently no selective delta agonists approved by the FDA.
The drug targets the delta opioid receptor, one of three opioid receptors that modulate pain and may have application in other indications.
“If the investigational new drug application (IND) becomes effective by the FDA without delay or the need for additional studies, Adolor expects to initiate a phase I clinical trial program in the first half of 2006,” said Dr James Barrett, chief scientific officer of Adolor.