AcelRx Pharmaceuticals (NASDAQ:ACRX) initiates a Phase 3 clinical trial, IAP312, assessing Zalviso (sufentanil sublingual tablet system) for the management of moderate-to-severe pain in adults in a hospital setting. The open-label study will enroll ~315 hospitalized, post-operative patients who will self-administer sublingually (under the tongue) 15 mcg of sufentanil as often as every 20 minutes for 24 - 72 hours to manage their pain.
In addition to safety and efficacy measures, the study will collect usability data, including the product's failure to dispense medication and the incidence of dropped/misplaced tablets.
The trial is being conducted at the request of the FDA. The aim is to assess the risk of inadvertent dispensing and the overall risk of dispensing failures because to the high potency of sufentanil (1000x more powerful than heroin). Three previous Phase 3 studies were successful. According to ClinicalTrials.gov, the estimated study completion date is April 2017.
Zalviso is a hand-held device that dispenses a sublingual dose of the synthetic opioid. Its value proposition is a longer durability of analgesic effect compared to an IV pump with less risk of dosing errors due to pump programming errors and the elimination of complications associated with IV catheters. It was approved in Europe in September 2015.
Previously: AcelRx set to begin new (hopefully final) late-study Zalviso study (Jan. 8)
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