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news.Collegium Pharmaceutical has completed enrollment of patients in the multi-center, double-blind, enriched enrollment, randomized withdrawal, placebo-controlled, safety, tolerability and efficacy Phase III trial of Oxycodone DETERx to treat moderate-to-severe chronic low back pain.
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The trial is designed to assess Oxycodone DETERx versus placebo in opioid-experienced and opioid-naïve subjects with moderate-to-severe chronic low back pain.
According to company, patients who achieve a stable and effective dose of Oxycodone DETERx during the Titration Phase are randomized into a 12-week, double-blind maintenance Phase in which they either maintain their current dose regimen of Oxycodone DETERx or are tapered to placebo.
The primary efficacy endpoint in the trial is the change in average pain intensity from baseline to week 12, while the secondary endpoints include evaluation of safety and tolerability, quality of life, physical disability, and global impression of change.
The company said that pain was measured by the pain intensity numerical rating scale (PI-NRS).
Collegium CEO Michael Heffernan said completion of enrolment in the Phase III trial marks the company’s continued progress in advancing this novel treatment for patients with chronic pain.
"In previously completed studies, Oxycodone DETERx demonstrated unique abuse-deterrent advantages when compared to currently marketed products," Heffernan said.
"In addition, Oxycodone DETERx would be the first abuse-deterrent, extended-release opioid suitable for administration via a sprinkle to patients with concurrent chronic pain with dysphagia (difficulty swallowing), a debilitating condition that effects approximately 11 million patients in the US."
Top-line results of the Phase III trial are expected to be released in the second quarter of 2014, following which the company will file an NDA for Oxycodone DETERx.
The DETERx drug delivery platform, which features tamper-resistant properties to protect against chewing, crushing, insufflation and extraction for IV injection, 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.