Nova Mentis NM-1001 Psilocybin Compound Gets DEA Approval For Export, Here's What Happened

Nova Mentis Life Science Corp. NMLSF, also known as NOVA, a biotech company developing psilocybin-based therapeutics and complementary diagnostics for neuroinflammatory disorders, recently received the required controlled substances export approval from the U.S. Drug Enforcement Administration (DEA) for its proprietary psilocybin drug (NM-1001).

The company’s goal is to diagnose and treat chronic conditions such as autism spectrum disorder (ASD) and Fragile X Syndrome (FXS) or Martin-Bell syndrome, one of the largest genetic causes of autism spectrum disorders. One interesting thing about the company is that, according to their statements, they are the first biotech to achieve orphan drug designation in both the United States and the European Union for the use of psilocybin in the treatment of Fragile X Syndrome (FXS). 

With this permit, the company completed the successful import of its proprietary psilocybin drug (NM-1001) into Canada to the Toronto Institute of Pharmaceutical Technology (TIPT) labs, in order to formulate and manufacture psilocybin microdose capsules for a planned Phase 2A fragile X syndrome clinical study.

As NOVA president and CEO Will Rascan said, "This allows us to move forward with the formulation and final production of microdose capsules in preparation for our clinical trial application submission to Health Canada. We look forward to continuing to advance our research program to demonstrate the important role that microdose therapy may play in the treatment of autism spectrum disorder and FXS."

The company is conducting this study in different parts of the world. Earlier this year, NOVA announced that a very low microdose formulation of the Company's proprietary psilocybin drug (NM-1001) significantly modulated behavioral and cognitive defects, such as recognition memory, in a genetic model of FXS. 

In the US, the enrollment for the study began in March and is still open to those interested.

Photo Courtesy of Hybrid on Unsplash.