Vancouver-based PharmAla Biotech Holdings Inc. (CSE: MDMA) and Filament Health Corp. (OTCQB: FLHLF) (NEO:FH) (FSE:7QS) have launched their GMP-certified MDMA capsules to be used in clinical trials and by authorized patients in Canada and around the world.
PharmAla announced the agreement on Tuesday where Filament’s subsidiary Psilo Scientific will manufacture the MDMA capsules using PharmAla’s previously-manufactured GMP LaNeo MDMA active pharmaceutical ingredient. The MDMA is capsuled at Psilo Scientific’s certified facilities.
PharmAla’s CEO Nick Kadysh said that for a long time now, the company has been dedicated to addressing the shortage of MDMA available for clinical research worldwide. As the psychedelics industry progresses, there is expected to be an increase in the quantity of clinical research on MDMA.
“Our eyes are now fully set on jurisdictions like Australia, which will require full commercial-scale manufacturing of both GMP API and drug product to fulfill the demand for patients – and those jurisdictions still to come,” Kadysh said.
“The GMP release of MDMA drug product is an exciting step for the psychedelic industry, and indicative of our manufacturing capability,” Filament CEO Benjamin Lightburn said. “MDMA has shown promise for treating a range of health conditions and we’re proud to support PharmAla’s efforts to improve access.”
Read more: PharmAla Biotech signs agreement to sell clinical-grade MDMA in Australia
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PharmAla has an exclusive supply agreement with the pharmaceutical company Revive Therapeutics Ltd. (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT: 31R) for its GMP-certified LaNeo MDMA. Revive uses the patented MDMA for the research and development of its novel transdermal microneedle patch.
Last Month, PharmAla announced an agreement with Awakn LS Europe Holdings Limited (CSE:AWKN) where PharmAla will be its exclusive supplier of MDMA. David Nutt, who was a founding board member of PharmAla, left PharmAla’s board in order to take on the role of Chief Research Officer at Awakn.
In February, the company signed an agreement to sell a batch of its patented MDMA to the Australian drug developer Emyria Limited (ASX: EMD) (ASX: EMD). The announcement came after the Australian Government’s Therapeutic Goods Administration said it will allow psychiatrists to prescribe MDMA for post-traumatic stress disorder and psilocybin for treatment-resistant depression. The changes will be effective as of July this year and some companies have started to look at importing MDMA into the country.
PharmAla holds the distinction of being among the initial publicly listed firms to produce GMP MDMA and offers two clinical-grade psychedelic APIs for research purposes.
PharmAla stock went up by 20 per cent Tuesday to $0.30 on the Canadian Securities Exchange.