4/27/2021 - 4:17 PM EST - Revive Therapeutics Ltd. : Announced it has filed an application with the U.S. Food and Drug Administration to receive Orphan Drug Designation for Psilocybin to treat moderate to severe traumatic brain injury. Michael Frank, CEO of Revive commented: “The FDA orphan drug application for psilocybin to treat moderate to severe TBI is an important milestone for Revive as we focus on building a robust product pipeline focused on novel uses and delivery forms of psilocybin to treat significant unmet medical needs. We are currently seeking to evaluate psilocybin in a clinical trial for moderate to severe TBI and advancing our development of a proprietary oral thin film psilocybin product for the potential treatment of certain neurological disorders, such as brain damage caused by all forms of TBI and stroke, and other related mental health and substance abuse disorders.” Revive Therapeutics Ltd.
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