Buprenorphine sublingual spray meets primary endpoint in phase III trial for moderate to severe postoperative pain - Insys Therapeutics

Insys Therapeutics has reported that the Phase III trial for the buprenorphine sublingual spray met its primary endpoint for moderate to severe pain. The trial was a multicenter, randomized, double-blind, multiple-dose, placebo-controlled study evaluating the efficacy and safety of three dosing regimens of Buprenorphine Sublingual Spray (0.5 mg three times daily, 0.25 mg tid, or 0.125 mg tid), and/or matching placebo in subjects with moderate to severe postoperative pain after bunionectomy. 322 subjects were randomized.

As agreed with the FDA, the primary efficacy endpoint in this study was the Summed Pain Intensity Difference relative to baseline over a period of 48 hours (SPID-48). The patient assessment of pain intensity utilized a numeric pain scale (11-point scale with 0 = no pain to 10 = worst possible pain). The primary efficacy endpoint was statistically significant at all doses studied. The Buprenorphine Sublingual Spray 0.5 mg tid demonstrated the largest reduction in SPID-48 and was statistically significant to placebo. The 0.25 mg tid and 0.125 mg tid doses also demonstrated statistically significant reductions in SPID-48 (p = 0.0108 and p = 0.0120, respectively). All treatments were generally well tolerated.