Revive Therapeutics Gets Nod From FDA, Could Conduct Psilocybin Study Trials In 2023

A life sciences company developing dissolvable, oral psilocybin film-strips to treat could conduct its first-in-human clinical study as soon as next year.

On Friday, Revive Therapeutics Ltd. (OTCQB: RVVTF) (CSE: RVV) gave an update on the company’s Phase I/II clinical study of oral psilocybin to treat mental illness, substance abuse, and neurological disorders.

Prototypes of the oral psilocybin thin film strip product have been developed and are being optimized for use in upcoming IND-enabling studies.

“We intend to advance the development of our oral psilocybin thin film strip product for these indications,” said Derrick Welsh, COO of Psilocin Pharma, a division of Revive.

The company has initiated the product development program under a feasibility agreement with LTS Lohmann Therapie-Systeme AG, a leader in pharmaceutical oral thin films, to develop and manufacture a proprietary oral psilocybin thin film strip product for mental illness, substance abuse, and neurological disorders.

“In parallel, we are working on our first clinical study evaluating oral psilocybin in the treatment of methamphetamine use disorder to validate its use in substance abuse indications,” Welsh added.

The company has been evaluating the use of oral psilocybin as a potential treatment for methamphetamine use disorder with the University of Wisconsin-Madison’s School of Medicine and Public Health and School of Pharmacy.

The Phase I/II clinical study looking at the safety and utility of psilocybin in adults with methamphetamine use disorder received both FDA and Institutional Review Board approval.

The clinical data that is generated from the study will provide proprietary and valuable information on the safety, efficacy, and dosing of oral psilocybin to support future pivotal FDA clinical studies for the company’s proposed oral psilocybin thin film strip product.

In addition, the company will have exclusive access to the intellectual property moat from this study to support development, regulatory and commercial initiatives.

“The clinical data from this study will be used to support late-stage clinical trials with our oral psilocybin thin film strip product,” Welsh said.

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