Orexo Announces FDA Acceptance of IND Application for OX640 for Anaphylaxis Treatment

Orexo AB has announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for OX640. This nasally administered powder formulation of epinephrine is intended for the emergency treatment of anaphylaxis, enabling the initiation of a pivotal clinical development program. OX640, developed using Orexo's AmorphOX® drug delivery platform, has shown rapid absorption, good tolerability, and a strong stability profile in clinical studies.