Oxycodone extended-release using gel-cap technology to resist alteration and abuse for the treatment of moderate-to-severe pain.

SUMMARY Abuse of commercial oxycodone extended-release is common, fueling motivation by drug developers to investigate new formulations intended to resist alteration and abuse without compromising effective around-the-clock analgesia. An oral formulation of oxycodone extended-release that uses gel-cap technology as a tamper-resistant barrier is currently in development. Gel-cap oxycodone extended-release met the primary end point of significantly improved mean pain intensity scores compared with placebo in a Phase III, placebo-controlled trial. In studies of abuse liability, preliminary results indicate the formulation could be less attractive to would-be abusers. Unanswered questions include whether less real-world abuse and increased safety would follow product launch and how this and other formulations aimed at reducing abuse potential might affect adherent patients.

RCT Entities:   Population Interventions Outcomes