Catalyst
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AcelRx (ACRX) Initiates Phase 3 Study of Zalviso in Patients with Moderate-to-Severe Acute Post-Operative Pain
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Additional Information
Three Phase 3 studies for Zalviso in a total of 768 patients have been completed to date: IAP309, IAP310 and IAP311, detailed information for which may be found on www.clinicaltrials.gov. In brief, IAP309 was a Phase 3 open-label, active comparator study, in which Zalviso was shown to be non-inferior (p<0.001), as well as superior (p=0.007), to intravenous (IV) PCA morphine based on the primary endpoint of Patient Global Assessment method of pain control comparison over the 48-hour trial period (PGA48). IAP310 and IAP311 were Phase 3 double-blind, placebo-controlled studies in which patients treated with Zalviso to manage their post-operative pain reported a greater summed pain intensity difference to baseline over 48 hours (SPID48, the primary endpoint) compared to placebo-treated patients (p=0.001 and p<0.001, respectively). The most common adverse events experienced by patients using Zalviso in these clinical studies were nausea, pyrexia (fever) and vomiting.
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Catalyst Date
Occurred on:
Sep 27, 2016
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Related Keywords
Zalviso, Post-operative Pain, Sufentanil Sublingual Tablet System, Iap312 Study