Revive Therapeutics (CSE: RVV) has filed for orphan drug designation with the US Food and Drug Administration. The filing relates to the use of psilocybin for the treatment of moderate to severe traumatic brain injury.

Psilocybin, as per Revive, currently offers a potential solution to manage moderate to severe cases of traumatic brain injury, or TBI. The compound may have the potential to improve the loss of cognitive function due to its neuroreparative effects, lessening disability related to such cases of TBI. Pre-clinical trials conducted on mice related to the use of psilocybin in TBI have shown that cognitive function improves after the administration of psilocybin.

Currently, there are no approved treatments by the FDA for cognitive impairments as a result of traumatic brain injuries. Moderate to severe cases of TBI is known to potentially lead to a number of changes over a persons life, with 50% of such cases leading to death within 9 years of injury or a further decline in their quality of life.

“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.”

Michael Frank, CEO of Revive

Revive Therapeutics last traded at $0.485 on the CSE.


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