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# AcelRx Hears from FDA on Zalviso Protocol
- URL: https://www.fdaweb.com/acelrx-hears-from-fda-on-zalviso-protocol/
- Published: 2016-01-08T12:00:00.000Z
- Updated: 2026-09-15T02:26:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134389

AcelRx Pharmaceuticals, Inc. says it has received comments from FDA’s Division of Anesthesia, Analgesia and Addiction Products on its proposed protocol for a Phase 3 clinical study (IAP312) to assess the overall performance of Zalviso (sufentanil sublingual tablet system) for managing moderate-to-severe acute pain in adult patients in the hospital setting. According to the company, FDA requested the IAP312 study in a 7/25/14 Complete Response Letter to the company’s NDA. It plans to begin the study this quarter in about 310 post-operative patients who will self-administer 15 mcg Zalviso for 24-to-72 hours. It says it will also collect information that was requested by FDA from three already completed Phase 3 trials.