AcelRx: FDA declined to issue EUA for Niyad at this time

In a regulatory filing, AcelRx said that as previously disclosed on April 27, the company submitted a request to the U.S. Food and Drug Administration for Emergency Use Authorization for Niyad, for use as a regional anticoagulant in patients receiving Continuous Renal Replacement Therapy who cannot tolerate heparin or are at a higher risk of bleeding. On September 22, the FDA notified the company that due to the volume of EUA requests the FDA has received, the FDA has determined that review of the Niyad EUA is not a priority and has therefore declined to issue an EUA for Niyad at this time pursuant to the FDA’s current prioritization of EUA requests. In the notice letter, the FDA encouraged the company to continue to assess clinical development of the Niyad device. The company plans to initiate a registrational study of Niyad later this year and anticipates submitting a Pre-Market Application for Niyad to the FDA in 2024.