MDXX-class molecules producer PharmAla Biotech Holdings Inc. and natural psychedelics developer Filament Health Corp's FLHLF partnership is seeing the release of GMP-compliant MDMA capsules for distribution to clinical trials and authorized patients in Canada and worldwide.
The agreement entails that Filament’s subsidiary Psilo Scientific will manufacture MDMA capsules for PharmAla using the previously-manufactured GMP LaNeo MDMA Active Pharmaceutical Ingredient (API) in its Health Canada licensed facility located at Metro Vancouver.
PharmAla’s CEO Nick Kadysh said the company has been working for some time to fill the MDMA backlog for clinical researchers at a global scale.
“As the psychedelics industry matures, the amount of clinical research for MDMA is set to grow,” Kadyshs noted. Adding that PharmAla is now focused on jurisdictions like Australia, “which will require full commercial-scale manufacturing of both GMP API and drug product to fulfill demand for patients,” and other jurisdictions still to come.
PharmAla will present its vision for the future of the commercial MDMA market at the Benzinga Psychedelics Capital Conference in Miami on April 13th.
On behalf of Filament, CEO Benjamin Lightburn commented that “the GMP release of MDMA drug product is an exciting step for the psychedelic industry,” considering the compound has shown promise in treating a range of health conditions, and that it proves the company’s manufacturing capability.
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Photo: Benzinga edit with photo by luchschenF and ANDREI ASKIRKA on Shutterstock.
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