Oxycodone hydrochloride controlled‐release tablets (OxyContin®): post‐marketing surveillance (PMS) study for relieving moderate to severe non‐cancer pain

Objective: To evaluate the efficacy and safety of oxycodone hydrochloride controlled‐release (CR) tablets (Oxycontin®, Mundipharma International Limited, Cambridge, UK), 5 mg, 10 mg, 20 mg, and 40 mg in relieving moderate to severe non‐cancer pain.Method: Two multi‐center, open‐label, prospective, self‐controlled clinical trial, used identical protocols. All the subjects were patients with moderate to severe non‐cancer pain. The clinical data were collected in the natural course of clinical treatment.Results: Treatments with oxycodone CR tablets was associated with fast onset on pain relief; 85.2% of patients in study 1 and 91.8% of patients in study 2 achieved pain relief within 1 hour of drug administration.Clinical efficacy: Both studies demonstrated that oxycodone CR tablets showed good clinical efficacy for relieving both moderate and severe non‐cancer pain. Patients experienced sustained pain relief from the first week of treatment. Patients in both study 1 and study 2 experienced a dramatic pain score reduction (as assessed by VAS) after the first week of treatment.Safety profile: During oxycodone CR treatment, use of concomitant medications decreased significantly. A few patients developed ADRs in the first week, which decreased significantly as the treatment continued. Constipation was the most common ADR in the first week, which decreased to 10% of patients from the second week of treatment.Conclusion: Oxycodone CR tablets demonstrated fast onset of pain control and superior efficacy for relieving both moderate and severe non‐cancer pain, as well as significant reductions in the number of concomitant medications, demonstrating a good safety profile.