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12-Month safety and effectiveness of once-daily hydrocodone

Warren Wen, PhD, Louise Taber, MD, Shau Yu Lynch, PhD, Ellie He, PhD, Steven Ripa, MD


Objective: To characterize the long-term safety and effectiveness of Hysingla™ ER, single-entity, once-daily, extended-release hydrocodone bitartrate tablets formulated with abuse-deterrent properties (HYD), offering a new treatment option for appropriate patients with chronic pain.

Design: An open-label study with a dose-titration period (up to 45 days) and a maintenance period (12 months).

Patients, participants: A total of 922 patients with chronic nonmalignant and non-neuropathic moderate to severe pain received open-label HYD tablets 20-120 mg; 728 of these achieved a stabilized dose of HYD at the end of dose-titration and entered the maintenance period.

Results: The safety profile was similar to that of other oral opioid analgesics, without new or unexpected safety concerns. The most frequent treatment-emergent adverse events (AEs; 5 percent) were those commonly associated with the use of systemic μ-opioid analgesics, including nausea, constipation, vomiting, fatigue, dizziness, somnolence, and headache. There were 77 (8 percent) patients with a total of 109 nonfatal treatment-emergent serious AEs. Few patients discontinued due to lack of therapeutic effect overall (6 percent), especially during the 12-month maintenance period (4 percent). Pain relief, sleep, functional health, and activities of daily living all improved at the end of the dose-titration period with HYD. These improvements were maintained through the 12-month maintenance period with stable HYD doses and without increase in concomitant supplemental analgesic medications.

Conclusions: This long-term study demonstrated the safety and long-term maintenance of analgesic effect of HYD without continued need for dose increase.


hydrocodone, opioid, chronic pain, analgesics, long-term safety

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