Approval Advances Psilocybin Treatment Plans in Canada

Margarida Maia, PhD avatar

by Margarida Maia, PhD |

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Nova Mentis has received the green light from the U.S. Drug Enforcement Administration (DEA) to ship psilocybin (NM-1001) into Canada, moving it a step closer to being tested as a treatment for fragile X syndrome.

Psilocybin arrived recently at the labs of the Toronto Institute of Pharmaceutical Technology (TIPT), where it will be used to make capsules containing very small doses (microdoses) of the compound.

The company, together with KGK Science, is planning to ask Health Canada soon for the go-ahead to launch a Phase 2 clinical trial that would test the microdoses of psilocybin as a treatment for fragile X.

“Nova is excited to have completed the successful import of our proprietary psilocybin drug (NM-1001) into Canada,” Will Rascan, president and CEO of Nova, said in a press release.

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“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,” Rascan added.

Fragile X is a genetic disease caused by mutations in the FMR1 gene, located in the X chromosome. It can result in a range of developmental delays and cognitive disabilities. People with fragile X often also have social and behavioral problems, including those that are characteristic of disorders of the autism spectrum.

While there is no cure for fragile X, some treatments can ease disease symptoms.

Psilocybin is a hallucinogen that can produce distortions in sensations and changes to mood and thought processes. Used in microdoses, psilocybin no longer acts as a hallucinogen, but retains a wide range of other effects.

Earlier this year, Nova announced that treatment with microdoses of psilocybin in an animal model of fragile X significantly improved cognitive and behavioral problems, such as recognition memory or the ability to identify a situation as familiar.

“Our science team has delivered promising preclinical results and 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 [fragile X],” said Rascan.

Nova has received orphan drug designation in the U.S. and the European Union for the use of psilocybin in the treatment of fragile X.