Safety and Effectiveness of Once-Daily Hysingla Extended-Release Tablets in Patients with Baseline Depression or Anxiety

Abstract

Aim: Long-term safety and effectiveness of a once-daily, single-entity, extended-release formulation of hydrocodone bitartrate (HYD) for the treatment of moderate to severe noncancer and nonneuropathic pain among patients with and without concurrent depression/anxiety at baseline. Materials & methods:Post hoc analysis. Results: HYD demonstrated a safety profile consistent with μ-opioid agonists: Serious adverse events in 12% patients with depression/anxiety including four deaths; 6% without depression/anxiety including one death. All pain scores declined by ≥2 points and mean daily HYD dose remained stable in both subgroups. Conclusion: More serious adverse events occurred among patients with comorbid depression/anxiety at baseline than among those without. HYD provided stable and effective analgesia for 52 weeks among chronic pain patients with and without comorbid depression/anxiety at baseline.

KEYWORDS:

• anxiety
• chronic pain
• depression
• hydrocodone bitartrate
• long-term opioid therapy

Financial & competing interests disclosure

This study was sponsored and funded by Purdue Pharma, LP, Stamford, CT. E He and R Ripa are employees of Purdue Pharma LP, Stamford, CT. L Taber was an investigator for the study. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Medical writing and editorial support were provided by S Kongara, and funded by Purdue Pharma LP, Stamford, CT.

Ethical conduct

The authors state that they have obtained appropriate Institutional Review Board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.