The phase I study is designed to investigate the safety and tolerability of a single dose of the drug in healthy volunteers. As a next step in the development, the company plans to conduct a multi-dose safety study.
Adolor submitted an investigational new drug application with the FDA in December of 2005. After reviewing the application, the FDA placed the application on clinical hold pending additional acute toxicity information. The FDA reviewed the company’s complete response and lifted the clinical hold, allowing for the initiation of the phase I clinical trial.
“Discovered in-house, ADL5859 is Adolor’s third product currently in clinical development and represents a new class of potential analgesics,” said James Barrett, senior vice president of research and development, Adolor.
The delta receptor is one of three opioid receptors that modulate pain and may have application in other medical conditions. Adolor has discovered a series of selective delta agonists, with the lead candidate, ADL5859, showing analgesic activity in preclinical evaluation. There are no selective Delta agonists approved by the FDA.