Collegium commences enrollment in Oxycodone DETERx Phase 3 study in chronic lower back pain

Collegium Pharmaceutical, Inc., a specialty pharmaceutical company focused on the development of innovative treatments for chronic pain today announced that it has initiated enrollment in its Phase 3 clinical study for Oxycodone DETERx^® (COL-003). This study is a randomized withdrawal, double-blind, placebo-controlled, enriched-enrollment, parallel-group, multicenter, 12-week clinical study in subjects with moderate-to-severe chronic lower back pain. The study is designed to compare the safety, efficacy and tolerability of Oxycodone DETERx^® vs. placebo.    

"The initiation of this study is a significant milestone for our lead product (COL-003) which utilizes our DETERx^® tamper-resistant, extended-release drug delivery technology," stated Michael Heffernan, President and CEO of Collegium. "In addition to this Phase 3 study, our development program for Oxycodone DETERx^® includes a comprehensive in vitro and in vivo characterization of the pharmacokinetics and tamper-resistant properties of the drug. We are very encouraged by the results to date which suggest that Oxycodone DETERx^® may offer a number of significant clinical advantages over currently marketed tamper-resistant opioids for the treatment of chronic pain. We expect to complete all of the required studies and submit the NDA by the end of 2013."