AcelRx Pharmaceuticals announced top-line data demonstrating that its Phase 3 study for investigational sublingual sufentanil NanoTab PCA (patient-controlled analgesia) System (NanoTab System), met the primary efficacy 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 post-operative pain.
The trial was a randomized, double-blind, placebo-blind, placebo-controlled study evaluating 426 adult patients for the treatment of moderate to severe acute pain immediately after major orthopedic surgery. Patients were randomized 3:1, with 315 patients randomized to sufentanil treatment and 104 to placebo treatment. Patients self-administered the treatment as needed, using the NanoTab System with a 20-minute lock-out period. Patients in both groups could receive up to 2mg morphine intravenously per hour as a rescue medication to enable placebo-treated patients to stay in the study. Pain scores were recorded just prior to the delivery of rescue medication. Patients were treated for a minimum of 48 hours and up to 72 hours. Results demonstrated that patients receiving sufentanil NanoTabs experienced a significantly greater reduction in pain as measured by SPID-48 vs. placebo (+76.1 vs -11.5, p<0.001).
AcelRx previously announced positive results for two other Phase 3 studies for the NanoTab PCA System for post-operative pain.
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