Insys Therapeutics (INSY) Announces Buprenorphine Sublingual Spray Phase 3 Met Primary Endpoint
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Insys Therapeutics, Inc. (Nasdaq: INSY) reported that the Phase 3 trial for the Buprenorphine Sublingual Spray met its primary endpoint.
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 (“tid”), 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 U.S. Food and Drug Administration (“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 (p<0.0001). 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.
“We are pleased with the results of this trial indicating that Buprenorphine Sublingual Spray could be a potentially useful drug for the treatment of moderate to severe pain and provide a valuable treatment option in a variety of clinical settings. We look forward to discussing these results with the FDA by the end of the year and subsequent next steps towards filing a New Drug Application,” said Dr. John Kapoor, Chairman, President and Chief Executive Officer, of Insys Therapeutics, Inc.
For more information about the trial, see https://clinicaltrials.gov/ct2/show/NCT02634788?term=NCT02634788&rank=1
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