Phase III trial data of Xtampza ER (oxycodone extended-release) in chronic low back pain meets endpoint and are published in Pain journal- Collegium Pharmaceutical

Collegium Pharmaceutical announced the publication of results from the Phase III clinical trial of Xtampza ER (oxycodone extended-release capsules). The study is published online in the August issue of the peer-reviewed journal Pain. The study was a multicentre, double-blind, enriched enrolment, randomised withdrawal, placebo-controlled, safety, tolerability and efficacy study of Xtampza ER versus placebo in opioid-experienced and opioid-naïve subjects with moderate-to-severe chronic low back pain.

The study met its primary endpoint, showing a statistically significant difference in average pain intensity from randomization baseline to Week 12 between the Xtampza ER and placebo groups (p<0.0001). All sensitivity analyses of the primary endpoint were also statistically significant. Xtampza ER had an adverse event profile consistent with other opioids, was well tolerated, and no new safety concerns were identified. These results demonstrate that Xtampza ER is effective in treating patients with moderate-to-severe chronic pain, was well-tolerated, and has a safety profile consistent with other ER/LA opioids.

Comment: Xtampza ER is the leading product candidate using Collegium's DETERx technology platform, which is designed to prevent abuse or misuse of the opioid component.