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Treatment for Pain

Adolor Corporation Submits Investigational New Drug Application for Novel Delta Opioid Agonist Compound for the Management of Pain

EXTON, Pa., December 29, 2005 -- Adolor Corporation announced today that it has submitted an investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) for ADL5859, a novel, oral compound that targets the Delta opioid receptor. Delta receptor agonists are thought to offer benefits over other approaches to the management of pain.

"ADL5859 was discovered by Adolor's research organization, reflecting the effectiveness of the company's strategy to have a productive internal research effort as well as an active effort to in-license and develop product candidates from outside the company," said James Barrett, Ph.D., senior vice president, chief scientific officer and president, research of Adolor Corporation. "If the IND becomes effective by the FDA without delay or the need for additional studies, Adolor expects to initiate a Phase 1 clinical trial program in the first half of 2006. ADL5859 will represent Adolor's third program in human clinical testing and is an important component of the company's growing pipeline."

The Delta receptor is one of three opioid receptors that modulate pain and may have application in other indications. Adolor has discovered a series of selective, novel Delta agonists. ADL5859 has shown activity and an attractive safety profile in preclinical evaluation and is under development for the potential relief of inflammatory and neuropathic pain. There are no selective Delta agonists approved by the FDA.

Posted: December 2005

ADL5859 FDA Approval History

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