Journal of opioid management
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Randomized Controlled Trial
Efficacy and safety of a hydrocodone extended-release tablet formulated with abuse-deterrence technology in patients with moderate-to-severe chronic low back pain.
To evaluate efficacy and safety of hydrocodone bitartrate extended release (ER) tablets developed with CIMA(®) Abuse-Deterrence Technology (ADT) versus placebo in alleviating moderate-to-severe pain in patients with chronic low back pain. ⋯ Hydrocodone ER formulated with ADT was significantly more effective than placebo in alleviating chronic low back pain and demonstrated a safety profile consistent with that of opioids, with a low occurrence of study drug loss and diversion.
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Multicenter Study Clinical Trial
Pain intensity and interference with functioning and well-being in subgroups of patients with chronic pain treated with once-daily hydrocodone tablets.
A previous 52-week trial of patients with chronic noncancer, non-neuropathic pain (CNNP) showed clinically meaningful improvement in pain intensity, pain interference, and physical health-related quality of life (HRQL) following daily treatment with an extended-release, once-daily hydrocodone (Hysingla(®) ER; HYD) bitartrate tablet. ⋯ Regardless of subgroup, patients with CNNP treated with HYD showed clinically meaningful improvements in pain intensity, pain interference, and physical HRQL, although not in mental HRQL or sleep quality. Improvements were generally larger for opioid-naïve patients and patients with severe baseline pain.