Phase 3 Study Initiated for Patient-Controlled Analgesia System Zalviso
AcelRx has announced the initiation of the Phase 3 IAP312 study of Zalviso (sufentanil sublingual tablet system), an investigational treatment for the management of moderate-to-severe acute pain in adult patients.
Zalviso is a preprogrammed, patient-controlled analgesia (CPA) designed to dispense a non-invasive sublingual formulation of sufentanil. Approximately 315 hospitalized, post-operative patients will be enrolled in the study, who will self-administer the 15microgram sublingual tablets as often as once every 20 minutes for 24-72 hours.
In addition to safety and efficacy measures, the study will collect information on device usability, including any incidence of Zalviso's failure to dispense medication as well as the incidence of misplaced or dropped tablets.
Three Phase 3 Studies of Zalviso have been completed: IAP309, IAP310 and IAP311. In IAP309, Zalviso was shown to be non-inferior (P<0.001) and superior (P=0.007) to intravenous PCA in pain control over 48 hours. IAP310 and IAP311 showed that patients treated with Zalviso to manage their post-operative pain reported a greater summed pain intensity difference to baseline over 48 hours compared to placebo-treated patients (P=0.001 and P<0.001, respectively).
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