(457) Effectiveness of Hysingla® ER, a once-daily, single-entity, hydrocodone with abuse-deterrent properties in treating chronic nonmalignant and nonneuropathic pain in patients with depression and anxiety

Abstract

Chronic pain commonly co-occurs with depression and anxiety disorders. Patients with these comorbid conditions generally have poor overall response to pain treatments. This post-hoc analysis evaluated the effectiveness and tolerability of Hysingla® ER, a once-daily, single-entity, hydrocodone (HYD) formulated with abuse-deterrent properties in the treatment of moderate-to-severe chronic pain in patients with depression and/or anxiety disorders. Data were from an open-label, long-term study in patients with chronic nonmalignant and nonneuropathic pain. The tolerability and effectiveness of HYD on pain and function were evaluated. Of the 922 patients in the study, 352 (38%) patients had depression and/or anxiety disorders at baseline. Of these, 285 (81%) patients entered the 12-month maintenance period after having their HYD doses successfully titrated to a level that was tolerated and provided adequate analgesia (mean average daily dose was 69 mg). Of the 285 patients, 158 (55%) completed the 12-month maintenance treatment; 41 (14%) and 19 (7%) discontinued treatment due to adverse events (AEs) and lack-of-therapeutic effect, respectively. The most common treatment-emergent AEs (occurred in ≥10% patients) were nausea, constipation, somnolence and headache. Clinically important pain reduction (ie, ≥2 points on an 11-point numerical rating scale) from baseline was achieved at the end of the titration period (mean reduction of 2.2 points from baseline) and patients experienced less pain interference with daily function and mood (mean reduction of 2.1 from baseline in the Brief Pain Inventory pain interference subscale). This treatment effect was similar to that of the overall population and was maintained throughout the 12-month maintenance period. During the maintenance period, 65% of the patients did not require HYD dose adjustment; 21% increased their HYD doses to 1 dose level higher; 4% increased to 2 dose levels or higher. In this study, HYD effectively treated many chronic pain patients with comorbid depression or/and anxiety disorders.