Insys Therapeutics' Buprenorphine Sublingual Spray Trial Meets Primary Endpoint

(RTTNews) - Insys Therapeutics, Inc. (INSY) reported Wednesday that the Phase 3 trial for the Buprenorphine Sublingual Spray met its primary endpoint.

Insys is developing Buprenorphine Sublingual Spray for sublingual administration as a treatment 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, and/or matching placebo in subjects with moderate to severe postoperative pain after bunionectomy.

As agreed with the U.S. Food and Drug Administration, the primary efficacy endpoint in this study was the Summed Pain Intensity Difference relative to baseline over a period of 48 hours.

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.

The company will discuss these results with the FDA by the end of the year and subsequent next steps towards filing a New Drug Application.