Opioid-Sparing Effects of SoluMatrix Indomethacin in Patients With Acute Postoperative Pain

Title: Opioid-sparing Effects of SoluMatrix Indomethacin in a Phase 3 Study in Patients with Acute Postoperative Pain

Gharibo, C et al.


What You Need to Know:

According to results of a phase 3 study, SoluMatrix indomethacin exhibited opioid-sparing effects in patients with acute postoperative pain following bunionectomy surgery.

Trial Design:

  • Placebo-controlled phase 3 study evaluated the opioid-sparing effects of SoluMatrix indomethacin in patients with acute moderate-to-severe pain after undergoing bunionectomy surgery
  • 462 patients were randomized to receive 40mg SoluMatrix indomethacin three times daily, 40mg SoluMatrix indomethacin twice daily, 20mg SoluMatrix indomethacin three times daily, 200mg celecoxib twice daily following a 400-mg loading dose, or placebo
  • Evaluated the proportion of patients that required rescue medication, the amount of rescue medication required on Days 1 and 2 after administration of the initial dose of study medication, and the time to first rescue medication use

Key Outcomes:

  • On day 1, opioid-containing rescue therapy was required by fewer patients in the 20- and 40-mg SoluMatrix indomethacin three times daily treatment groups vs patients in the placebo group (P0.034)
  • On day 2, rescue medication use was required by fewer patients in all active treatment groups vs placebo (P<0.001)
  • All active treatment groups required fewer rescue medication tablets compared to placebo on both day 1 and day 2 (P<0.001)
  • Common adverse events: nauseas, postprocedural edema, headache