[Source: INSYS Therapeutics] – INSYS Therapeutics, Inc. announces positive results from the pivotal phase III efficacy trial for patients utilizing the Fentanyl Sublingual Spray (SL Spray) technology to treat breakthrough cancer pain. All primary and secondary endpoints were achieved in the study, and the drug is the first product to ever show statistically significant pain relief when measuring the summary of pain intensity difference at five minutes (SPID(5)) in a phase III breakthrough cancer pain trial using Fentanyl.
The primary endpoint of the study was to measure the summary of pain intensity difference at thirty minutes (SPID (30)) compared to placebo. INSYS’ SL Spray significantly improved mean SPID (30) scores compared with placebo (p<0.0001). The SL spray significantly improved mean SPID values compared with placebo as early as 5 minutes (p=0.022), while all other endpoints starting at ten minutes showed the p value remaining at or less than 0.0001. Given breakthrough cancer pain’s rapid onset and often peak intensity at three to five minutes, it is vital to provide patients with a faster onset of action.