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Abuse-deterrent opioid sees positive Phase 3 results
October 2015
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CANTON, Mass.—Collegium Pharmaceutical Inc. recently published results from its Phase 3 clinical trial of Xtampza ER (oxycodone extended-release capsules) in opioid-experienced and opioid-naïve subjects with moderate-to-severe chronic low back pain. Xtampza ER is an abuse-deterrent, extended-release oral formulation of oxycodone developed with Collegium’s proprietary DETERx technology. The trial focused on the safety, tolerability and efficacy of Xtampza ER versus placebo, and Collegium’s drug was shown to meet the primary endpoint of a statistically significant difference in average pain intensity from randomization baseline to week 12 between the two groups. Xtampza ER’s adverse event profile was consistent with that of other opioids, and it proved to be well tolerated with no new safety concerns identified. The results were published in the journal PAIN.

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