Hydrocodone Bitartrate ER (Hysingla® ER): A Review in Chronic Pain

Abstract

Hydrocodone bitartrate extended-release (Hysingla^® ER; referred to hereafter as hydrocodone ER) was the first single-entity hydrocodone formulation recognized by the US FDA as having abuse-deterrent properties. It is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Once-daily oral hydrocodone ER provides consistent plasma hydrocodone concentrations and sustained analgesia over the 24-h dosing interval. Its physicochemical properties render hydrocodone ER harder to manipulate physically, which is expected to deter intranasal, intravenous and oral abuse. For instance, oral hydrocodone ER (intact or chewed) significantly reduced drug liking relative to hydrocodone solution in a clinical study. In two large phase III studies in patients with chronic pain, hydrocodone ER reduced pain intensity, with its effects seen early (during dose titration) and maintained during ≤76 weeks' treatment. During maintenance therapy, the majority of patients continued hydrocodone ER at the dosage achieved at the end of dose titration and without requiring increased doses of supplemental pain medication, suggesting adequate pain management. Hydrocodone ER was generally well tolerated, with a safety profile consistent with that seen with other μ-opioid analgesics. However, like other opioids, it is associated with risks of addiction, abuse/misuse and serious adverse events (AEs), including respiratory depression, withdrawal, physical dependence and overdose. Although large postmarketing studies are needed to determine whether the abuse-deterrent properties of hydrocodone ER result in meaningful reductions in abuse, misuse and related adverse clinical outcomes, current evidence indicates that hydrocodone ER is a useful treatment option for patients with chronic pain.