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

doi:10.5055/jom.2015.0283

Authors

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

DOI:

https://doi.org/10.5055/jom.2015.0283

Keywords:

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

Abstract

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.

Author Biographies

Warren Wen, PhD

Director, Clinical Research, Purdue Pharma L.P., Stamford, Connecticut

Louise Taber, MD

Medical Director, Arizona Research Center, Phoenix, Arizona

Shau Yu Lynch, PhD

Associate Director, Clinical Research, Purdue Pharma L.P., Stamford, Connecticut.

Ellie He, PhD

Associate Director, Biostatistics, Purdue Pharma L.P., Stamford, Connecticut

Steven Ripa, MD

Executive Medical Director, Clinical Research, Purdue Pharma L.P., Stamford, Connecticut.

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