Phase III analysis of Xtampza ER (oxycodone extended-release capsules) for chronic pain published in Current Medical Research and Opinion- Collegium Pharmaceutical
Collegium Pharmaceutical has announced the publication of an analysis of the duration of effect of Xtampza ER (oxycodone extended-release capsules) administered every 12 hours during the Double-blind Maintenance Phase of a multicenter, 12-week clinical study. The publication is titled, “Evaluation of the Durability of Pain Relief Throughout a 12-Hour Dosing Interval of a Novel, Extended-Release, Abuse-Deterrent Formulation of Oxycodone – Oxycodone DETERx” and is published in Current Medical Research and Opinion.
The analysis of the data from the Phase 3 randomized withdrawal, double-blind, placebo-controlled, enriched-enrollment, parallel-group, multicenter, 12-week clinical study in patients with chronic low back pain showed limited use of acetaminophen, the only rescue medication used in the study. In addition, the analysis showed no increase in rescue medication consumption from 8 to 12 hours after dosing, which is the time interval commonly associated with end-of-dose failure leading to inadequate analgesic effect; these data suggest that subjects maintained pain relief over the entire dosing interval with twice daily administration of Xtampza ER.
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