AcelRx Pharma (ACRX) Initiates Phase 3 IAP312 Study of Zalviso

September 27, 2016 7:02 AM EDT

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AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) announced today the initiation of the Phase 3 IAP312 study of Zalviso, an investigational product candidate being developed for the management of moderate-to-severe acute pain in adult patients in a hospital setting. IAP312 is a multicenter, open-label study designed at the request of the Division of Anesthesia, Analgesia and Addiction Products of the U.S. Food and Drug Administration (FDA). The IAP312 study will enroll approximately 315 hospitalized, post-operative patients who will use Zalviso to self-administer sublingually tablets containing 15 micrograms of sufentanil as often as once every 20 minutes for 24‑to-72 hours to manage their moderate-to-severe acute pain. In addition to safety and efficacy measures, IAP312 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.

Zalviso is a preprogrammed, patient-controlled analgesia (PCA) system designed to dispense a non-invasive sublingual formulation of sufentanil. Zalviso is currently approved by the European Commission and is marketed by Grunenthal GmbH, AcelRx's European commercial partner. Based on the Company's experience in previous clinical trials and in Europe, AcelRx has incorporated certain software and hardware revisions to improve device usability and optimize system functionalities. AcelRx has worked with its commercial supply chain partners to produce the clinical materials for use in the IAP312 study.

"Anecdotal experience from Grunenthal's Zalviso launch that began in April has been favorable, with patients and healthcare workers providing positive feedback on the pain control offered by sublingual sufentanil," commented Howie Rosen, AcelRx's chief executive officer. "We look forward to conducting the IAP312 study and submitting the findings to the FDA so that they may consider the product for approval here in the U.S. We will provide an update on study duration once we are further along with enrollment."

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 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.

"We designed Zalviso to have characteristics that would offer patients and healthcare providers benefits over IV morphine, the current standard of care for the treatment of moderate-to-severe acute pain in hospitalized patients," concluded Dr. Pamela Palmer, AcelRx's co-founder and chief medical officer. "The initiation of IAP312 is an important milestone, as it represents what we expect to be the last step in the Zalviso clinical development program, bringing a product that we believe can offer patients a new option for treating their moderate-to-severe acute pain, closer to market."

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