BioCentury
ARTICLE | Clinical News

Hydrocodone bitartrate ER: Clinical trial data

May 5, 2014 7:00 AM UTC

A double-blind, crossover trial in 35 healthy, non-dependent recreational opioid drug users showed that Purdue's abuse-deterrent, once-daily hydrocodone bitartrate ER when given either intact or chewed met the primary endpoint of lower drug liking scores measured up to 36 hours after dosing using a VAS vs. hydrocodone solution. Compared to hydrocodone solution, the proportion of patients with a >=30% reduction in maximum drug liking score was 83% for intact abuse-deterrent hydrocodone, 69% for chewed abuse-deterrent hydrocodone and 17% for a milled abuse-deterrent hydrocodone. Compared to hydrocodone solution, the proportion of patients with a >=50% reduction in maximum drug liking score was 74% for intact abuse-deterrent hydrocodone, 60% for chewed abuse-deterrent hydrocodone and 9% for milled abuse-deterrent hydrocodone.

A double-blind, crossover trial in 31 healthy, non-dependent recreational opioid drug users showed that Purdue's abuse-deterrent, once-daily hydrocodone bitartrate ER when given intranasally met the primary endpoint of lower drug liking scores measured up to 36 hours after dosing using a VAS vs. hydrocodone powder. Compared to hydrocodone powder, the proportion of patients with a >=30% reduction in maximum drug liking score was 68% for intranasal abuse-deterrent hydrocodone crushed into coarse particles and 72% for intranasal abuse-deterrent hydrocodone crushed into fine particles. Compared to hydrocodone powder, the proportion of patients with a >=50% reduction in maximum drug liking score was 64% for both coarse and fine intranasal abuse-deterrent hydrocodone. Data from both trials were presented at the American Pain Society meeting in Tampa. ...