AUSTIN, TX—In patients who have undergone a bunionectomy, both oxycodone 5mg/niacin 30mg and oxycodone 7.5mg/niacin 30mg were efficacious and generally provided more rapid analgesic onset than placebo in relieving moderate-to-severe pain, according to results of a study presented during American Pain Society’s 30th Annual Scientific Meeting.
Oxycodone HCl/niacin tablets are intended to relieve moderate-to-severe pain while providing impediments to potential misuse/abuse/diversion. In addition to oxycodone, each tablet contains a subtherapeutic amount of niacin (30mg)—intended to discourage excessive oral consumption—and functional inactive ingredients intended to discourage intravenous injection of dissolved tablets and nasal-snorting of crushed-tablets, noted Stephen E. Daniels, DO, of Premier Research Group Limited, Austin, Texas, and colleagues.
In a Phase 3, randomized, double-blind, placebo-controlled, multicenter, repeat-dose study, two oxycodone/niacin tablet-strengths were evaluated for relief of moderate-to-severe postoperative-pain following bunionectomy surgery. Patients (n=405) were randomized to receive two tablets of oxycodone 5mg/niacin 30mg, two tablets of oxycodone 7.5mg/niacin 30mg, or placebo, administered every 6 hours over a 48-hour treatment-period. Intravenous ketorolac tromethamine was available as rescue medication.
The primary endpoint of this study was the summed pain intensity difference over 48 hours (SPID48). Pain-intensity was measured on visual analog scale (VAS; 0=no pain; 100=worst imaginable pain) at scheduled time-points, prior to each study-medication dose, and prior to administration of any rescue medication. Pain relief was measured on a 5-point categorical scale (0=none, 4=complete). Time to first perceptible pain relief and time to meaningful pain relief were assessed using the two-stopwatch method. Site-personnel recorded timing and use of rescue medication.
Both dosage strengths of oxycodone/niacin demonstrated superiority to placebo in the primary outcome, time-weighted sum of pain-intensity differences over 48 hours (P≤0.0001 vs placebo), and in time-weighted sum of pain relief and pain intensity differences over the first 6 hours (P<0.0001).
Following the initial dose, oxycodone/niacin was statistically significantly superior compared with placebo for time to first perceptible pain relief (P=0.0008 and P<0.0001 for two tablets of oxycodone 5mg/niacin 30mg, and two tablets of oxycodone 7.5mg/niacin 30mg, respectively). Median time to perceptible pain was 0.8 hours and 0.5 hours for oxycodone 5mg/niacin 30mg and oxycodone 7.5mg/niacin 30mg compared with 5.8 hours for placebo. Also significantly superior to placebo was time of meaningful pain relief (P<0.0001, two tablets of oxycodone 7.5mg/niacin 30mg), and time to first use of rescue medication (P<0.0001 both strengths).
The most common adverse events (AEs) (placebo; oxycodone 5mg/niacin 30mg; and oxycodone 7.5mg/niacin 30mg, respectively) were nausea (10.3%, 50.4%, 61.9%), vomiting (3.7%, 34.1%, 50.0%), dizziness (4.4%, 16.3%, 23.9%), and flushing (1.5%, 16.3%, 11.2%), consistent with known effects of opioids, such as oxycodone, and/or niacin. Most AEs were mild or moderate in intensity and no serious AEs were reported. The studied was supported by Acura Pharmaceutical Technologies Inc., and King Pharmaceuticals, Inc.