Collegium enters Phase III with DETERx oxycodone
This article was originally published in Scrip
Collegium Pharmaceuticals, the private US company, is taking its lead product, a novel formulation of oxycodone, into a Phase III trial for chronic pain. The double-blind parallel group study will compare COL-003 with placebo over 12 weeks in patients with moderate-to-severe chronic lower back pain.
COL-003 uses the DETERx tamper-resistant, extended-release drug delivery platform consists of a multi-particulate matrix formulation in a capsule. It is primarily designed to be resistant to tampering in the form of chewing, crushing, insufflation and extraction for iv injection, but it also allows patients with difficulty swallowing to open the capsule and sprinkle the contents on food or via a gastronomy tube and still maintain its extended-release properties.
In addition to this Phase III study, Collegium's development program 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," said president and CEO Michael Heffernan.
Collegium expects to complete all of the required studies and submit the NDA by the end of 2013.
In February, the company raised $22.5 million in new financing to advance the development of COL-003, and which should support it through to FDA approval (scripintelligence.com, 27 February 2012).