AcelRx Pharmaceuticals announced top-line results demonstrating that the first of two pivotal placebo-controlled Phase 3 studies for its investigational sublingual Sufentanil NanoTab PCA (patient-controlled analgesia) System met its primary endpoint. The NanoTab System is an investigational pre-programmed, non-invasive, handheld system that allows post-operative patients to self-dose with sublingual Sufentanil NanoTabs to manage their post-operative pain.
This randomized, double-blind, placebo-controlled study enrolled 178 adult patients for the treatment of acute post-operative pain for a minimum of 48 hours, and up to 72 hours. Patients were randomized 2:1, with 119 patients randomized to sufentanil and 59 to placebo treatment. Both treatments were administered to the patient, as needed, using the NanoTab System with a 20-minute lock-out period. Patients in both groups could receive up to 2mg/hr of IV morphine as rescue medication. Rescue medication was provided to placebo-treated patients to enable them to stay in the study as long as possible. The primary endpoint of the study evaluated pain intensity over the 48-hour study period compared to baseline, or Summed Pain Intensity Difference (SPID-48), in patients following major open abdominal surgery.
The study’s primary endpoint was met with the results demonstrating that patients receiving sufentanil NanoTabs realized a significantly greater SPID-48 during the study period than placebo-treated patients (P=0.001).
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