Objectives: To report the opioid-sparing effects of SoluMatrix indomethacin, developed using SoluMatrix Fine Particle Technology, in a phase 3 study in patients with acute pain following bunionectomy.
Methods: This phase 3, placebo-controlled study randomized 462 patients with moderate-to-severe pain following bunionectomy surgery to receive SoluMatrix indomethacin 40 mg three times daily, SoluMatrix indomethacin 40 mg twice daily, SoluMatrix indomethacin 20 mg three times daily, celecoxib 400-mg loading dose followed by 200 mg twice daily, or placebo. Patients were permitted to receive opioid-containing rescue medication throughout the study. The proportion of patients who used rescue medication and the amount of rescue medication used on the first (0-24 h) and second (>24-48 h) days following initial dose of study medication, as well as time to first rescue medication use, were assessed.
Results: Significantly fewer patients who received SoluMatrix indomethacin 40 mg or 20 mg three times daily used opioid-containing rescue medication on day 1 compared with those receiving placebo (P<=0.034), and fewer patients in all active treatment groups used rescue medication during the second day compared with those in the placebo group (P<0.001). All active treatment groups used significantly fewer rescue medication tablets on days 1 and 2 following randomization compared with placebo (P<0.001). The most common adverse events were nausea, postprocedural edema, and headache.
Discussion: SoluMatrix indomethacin was associated with opioid-sparing effects in patients with acute postoperative pain.
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