A long-term, open-label safety study of single-entity hydrocodone bitartrate extended release for the treatment of moderate to severe chronic pain

Objective: To evaluate long-term safety of hydrocodone extended-release (ER) formulated with CIMA® Abuse-Deterrence Technology platform. Design: Phase 3, open-label study.Setting: Sixty-one US study centers.Patients: Patients with chronic pain newly enrolled or rolled over from a 12-week, placebo-controlled hydrocodone ER study; 330 patients enrolled, 329 patients received study drug, and 189 completed the study.Intervention: After titrating to an analgesic dose (15-90 mg every 12 hours), patients received ≤52 weeks of open-label treatment.Main outcome measures: Safety: adverse events (AEs), vital signs, laboratory values, electrocardiograms, and audiometry. Abuse potential: drug loss and diversion, Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R), Addiction Behaviors Checklist (ABC), Current Opioid Misuse Measure (COMM) questionnaires, and Patient Global Assessment (PGA) of pain control.Results: Of 329 patients who received ≥1 hydrocodone ER dose, 284 (86 percent) reported ≥1 AE and 27 (8 percent) experienced ≥1 serious AE. Sixty-two (19 percent) patients withdrew because of AEs, and two AEs leading to death were reported. No serious AEs or AEs leading to death were considered treatment related by the investigator. There were no clinically meaningful trends in other safety assessments. SOAPP-R, ABC, and COMM scores demonstrated low risk of aberrant drug-related behavior. Good/excellent PGA responses were reported by 20 percent of patients at baseline and 75 percent at endpoint. The incidence of drug loss (11 percent) and diversion (2 percent) was low.Conclusions: Hydrocodone ER demonstrated acceptable safety when administered for ≤12 months in patients with chronic pain. Low occurrence of aberrant drug-related behavior may support the abuse-deterrence properties of hydrocodone ER.

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(438) A 24-week extension of an open-label, long-term safety study evaluating the safety and effectiveness of once-daily, single-entity, hydrocodone in patients with chronic nonmalignant and non-neuropathic pain

Journal of Pain ◽

10.1016/j.jpain.2015.01.357 ◽

2015 ◽

Vol 16 (4) ◽

pp. S85

Author(s):

W. Wen ◽

L. Taber ◽

S. Lynch ◽

E. He ◽

S. Ripa

Keyword(s):

Neuropathic Pain ◽

Open Label ◽

Safety Study ◽

Once Daily ◽

Single Entity

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Relationship between change in pain intensity and functional outcomes in patients with chronic pain receiving twice daily extended-release hydrocodone bitartrate

Journal of Opioid Management ◽

10.5055/jom.2015.0291 ◽

2015 ◽

Vol 11 (5) ◽

pp. 417 ◽

Cited By ~ 6

Author(s):

Charles Argoff, MD ◽

Paul Arnstein, RN, PhD, FAAN ◽

Steven Stanos, DO ◽

Cynthia Y. Robinson, PhD ◽

Bradley S. Galer, MD ◽

...

Keyword(s):

Chronic Pain ◽

Pain Relief ◽

Extended Release ◽

Depression Scale ◽

Opioid Therapy ◽

Open Label ◽

Titration Phase ◽

Reported Study ◽

Post Hoc ◽

Hydrocodone Bitartrate

Objective: Evaluate levels of pain relief achieved in patients with chronic pain treated with hydrocodone-extended release (HC-ER) up to 48 weeks and show that these levels were associated with secondary functional and global outcomes.Design: Post hoc analyses were based on a previously reported study that started with an open-label conversion/titration phase for ≤ 6 weeks followed by an open-label 48-week treatment phase.Setting: Private practice and institutional pain centers.Participants: Three hundred ninety-one opioid-experienced subjects with moderate to severe pain for ≥3 months.Interventions: Individualized doses (20-300 mg) of extended-release hydrocodone every 12 hours.Main outcome: Almost 60 percent (232/391) of subjects achieved moderate or substantial levels of pain relief (≥30 percent reduction in pain score) during the study.Results: Subjects who achieved moderate or substantial pain relief demonstrated significant (p < 0.001) improvements in Oswestry Disability Inventory (ODI), all pain interference outcomes, and Subject Global Assessment of Medication. Subjects with substantial pain relief had decreases in ODI, Hospital Anxiety and Depression Scale (HADS) anxiety, and HADS depression scores of −13.4 ± 14.92, −1.9 ± 3.37, and −1.7 ± 3.26, respectively. The five most commonly reported treatment-emergent adverse events were constipation (12.5 percent), back pain (11.1 percent), nausea (9.9 percent), vomiting (9.7 percent), and arthralgia (7.8 percent) and are consistent with opioid therapy.Conclusions: Moderate or substantial levels of pain relief were associated with the greatest functional improvements in patients treated with HC-ER. These results may help define success of opioid therapy and determine if it should be continued or an alternative treatment should be tried.

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