AcelRx Receives IDE Approval for Niyad and Advances to a Single Registration Study

Provided By PR Newswire

Last update: Oct 3, 2023

Investigational Device Exemption (IDE) approval by the U.S. Food and Drug Administration (FDA) allows AcelRx to begin pivotal study of Niyad™

Single registration study with pre-agreed upon endpoints planned to initiate in Q4 2023 with topline data expected mid-2024; clinical site readiness is currently underway