Acelrx receives ide approval for niyad and advances to a single registration study

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 niyad would be the first and only approved regional anticoagulant in the u.s. for the extracorporeal circuit, if approved by the fda san mateo, calif. , oct. 3, 2023 /prnewswire/ -- acelrx pharmaceuticals, inc. (nasdaq: acrx), (acelrx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that it is advancing niyad™ (a lyophilized formulation of nafamostat) into a registrational study following the recent approval of an investigational device exemption (ide) submission to the united states food and drug administration (fda).
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