Egalet announced positive top-line results from a phase 3 study evaluating the safety of Egalet-002, an abuse-deterrent, extended-release oxycodone developed using an application of the Guardian Technology.
Egalet-002 was generally well-tolerated and the incidence of adverse events reported was generally consistent with outcomes expected following treatment with an extended-release oxycodone formulation.
"We believe the positive phase 3 safety study result validates this unique application of our Guardian Technology which was used to develop our abuse-deterrent, extended-release oxycodone, Egalet-002," said Bob Radie, president and chief executive officer of Egalet. "Given the ongoing issues of chronic pain and prescription abuse, we continue to believe there is a need for products like Egalet-002."
The objective of the open-label phase 3 study was to evaluate the safety and tolerability of Egalet-002 for up to 56 weeks in opioid-experienced patients with moderate-to-severe chronic noncancer pain. The goal of the study was to administer Egalet-002 to approximately 150 patients for six months and at least 50 patients for one year. The study enrolled 281 patients at 39 clinical sites in the United States who had a history of moderate-to-severe chronic non-cancer pain for six months or more.
In addition, a phase 3 trial evaluating the safety and efficacy of Egalet-002 in patients with moderate-to-severe chronic pain is expected to be completed by year end.