Collegium Pharmaceutical Announces Initiation of Enrollment in Phase 3 Efficacy Study of Oxycodone DETERx® in Subjects with Moderate to Severe Chronic Lower Back Pain
Collegium Pharmaceutical, Inc.Michael Heffernan, President, 401-762-2000, x220
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.”
The DETERx drug delivery platform consists of a multi-particulate matrix formulation in a capsule. While developed primarily to provide tamper-resistant properties to protect against common methods of tampering such as chewing, crushing, insufflation and extraction for IV injection, the multi-particulate design is expected to enable patients with difficulty swallowing to open the capsule and administer the contents on food or via a gastronomy tube, while maintaining the extended release properties of the product. DETERx technology can be used with drugs that are commonly abused such as opioids and amphetamines, as well as drugs that have narrow therapeutic windows that would benefit from protection against misuse such as breaking, crushing, grinding or dissolving the product. The formulation platform is covered by U.S. and international patents and patent applications. COL-003 is the first of a number of product candidates using the DETERx platform.
Collegium Pharmaceutical, Inc. is a specialty pharmaceutical company focused on developing a portfolio of products that incorporate its patent-protected DETERx formulation platform for the treatment of chronic pain.The DETERx oral drug delivery technology provides extended-release delivery, unique tamper-resistant properties, and flexible dose administration options. For more information, visit the Company’s website at .