Collegium Pharmaceutical, a specialty pharmaceutical company, has started enrolling subjects with moderate-to-severe chronic lower back pain in placebo-controlled, enriched-enrolment Phase III efficacy study of Oxycodone DETERx (COL-003).
The randomised withdrawal, double-blind, parallel-group, multicentre, 12-week clinical study is designed to compare the safety, efficacy and tolerability of Oxycodone DETERx versus a placebo.
The company’s lead product, COL-003, utilises its DETERx tamper-resistant, extended-release drug delivery technology, which consists of a multi-particulate matrix formulation in a capsule.
Collegium president and CEO Michael Heffernan said that the development programme for Oxycodone DETERx also includes a comprehensive in vitro and in vivo characterisation 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," Heffernan said.
"We expect to complete all of the required studies and submit the NDA by the end of 2013."
The DETERx drug delivery platform, which features tamper-resistant properties to protect against chewing, crushing, insufflation and extraction for IV injection, even allows 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.
The technology can be used with opioids and amphetamines, as well as drugs with narrow therapeutic windows.