Life sciences company Revive Therapeutics Ltd. RVVTF is advancing its first Phase I/II clinical trial of oral psilocybin for methamphetamine use disorder treatment while also developing an oral psilocybin thin film strip product.
Revive is currently studying psilocybin’s potential as treatment for the addiction of this particular stimulant drug together with the University of Wisconsin-Madison. The Phase I/II clinical trial holds both FDA and the Institutional Review Board approval, and is being led by Dr. Christopher Nicholas and Dr. Paul Hutson.
The clinical data is expected to give further insight on the safety, efficacy and dosing of oral psilocybin and, if applied, to support future clinical studies for Revive’s novel oral psilocybin thin film strip product to be conducted in 2023.
The company’s proprietary psilocybin product is being developed jointly with pharma oral thin films leader LTS Lohmann Therapie-Systeme AG. Prototypes of the new creation have been developed and are currently being optimized for its use in upcoming IND-enabling studies.
Revive is using its recently acquired Psilocin Pharma Corp. to advance the development of a psilocybin-based therapeutics pipeline for various health indications including mental illness, substance abuse and neurological disorders.
Meanwhile, the company also holds a cannabinoid pharma portfolio, which is focused on rare inflammatory diseases. The FDA granted Revive an orphan drug status designation for the use of cannabidiol (CBD) to treat autoimmune hepatitis and ischemia and reperfusion injury from organ transplantation.
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