US-based Collegium Pharmaceutical has completed patient enrolment in the phase 3 trial of its lead development programme Oxycodone DETERx for the treatment of moderate-to-severe chronic low back pain.
The multi-centre, double-blind, enriched enrolment, randomised withdrawal, placebo-controlled, safety, tolerability and efficacy trial is designed to evaluate Oxycodone DETERx versus placebo in opioid-experienced and opioid-naïve subjects with moderate-to-severe chronic low back pain.
The company said that patients who achieve a stable and effective dose of Oxycodone DETERx during the Titration phase are randomised 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.
In the trial, the primary efficacy endpoint is the change in average pain intensity from baseline to week 12, where pain was measured by the pain intensity numerical rating scale (PI-NRS). The secondary endpoints include evaluation of safety and tolerability, quality of life, physical disability and global impression of change.
Collegium CEO Michael Heffernan said: "Completion of enrollment in the phase 3 study marks our 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.
"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 affects approximately 11 million patients in the US."
The DETERx drug delivery platform consists of a multi-particulate matrix formulation in a capsule designed to enable patients with difficulty swallowing to open the capsule and administer the contents on food, directly in the mouth or via enteral tube, while maintaining the extended-release properties of the product.
According to the company, the DETERx oral drug delivery technology provides extended-release delivery, unique abuse-deterrent properties and flexible dose administration options.
DETERx technology was developed primarily to provide abuse-deterrent properties to protect against common methods of tampering and abuse such as chewing, crushing and insufflation.
Additionally, the company has completed abuse-deterrent studies that follow FDA’s ‘Abuse-Deterrent Opioids – Evaluation and Labeling’ draft guidance published in January 2013.
The Oxycodone DETERx abuse-deterrent programme includes a battery of in-vitro studies, three in-vivo pharmacokinetic studies and two clinical human abuse potential (HAP) studies.
The company has also completed all necessary studies to support product labelling, which will instruct patients with difficulty swallowing to open the capsule and administer the contents directly into their mouth, on food or via feeding tubes, while maintaining the extended-release properties of the product.
The company expects to release top-line results of the phase 3 trial in the second quarter of 2014, following which it will file an NDA for Oxycodone DETERx.
Image: Oxycodone DETERx is the first of a number of product candidates using the DETERx platform. Photo: courtesy of freedigitalphotos.net.