PharmAla Biotech Holdings Inc. (CSE: MDMA) and its distribution partner Shaman Pharma have received approval to provide MDMA to a physician that will be administering the drug through Health Canada’s Special Access Program (SAP).
The Vancouver psychedelics company announced the milestone on Tuesday and says Health Canada has confirmed that this is the first-ever authorization of MDMA-assisted therapy in the history of the program and the country aside from clinical trials.
PharmAla will not be charging the physician or the patient for its LaNeo MDMA product and says it will be delivered on a compassionate-use basis. The company plans to freely provide a certain amount of its MDMA for compassionate use within the SAP but says it eventually plans to charge patients on a cost-recovery basis for financial stability.
“It’s absolutely thrilling to be able to say that our GMP LaNeo MDMA will be used for the treatment of a patient in Canada. This regulatory milestone isn’t about financial impact, but healthcare impact,” said PharmAla’s CEO Nick Kadysh.
“Working in concert with PharmAla Biotech on this historic authorization, we’ve marked a significant step in the evolving narrative of MDMA’s potential therapeutic applications,” said Alexandre Grenier, CEO of PharmAla’s distribution partner CCrest Laboratories (operating as Shaman Pharma), adding that the approval was a testament to the companies dedication to science and advancements in patient care.
Health Canada’s Special Access Program allows health care professionals to request access to substances that are not authorized to be sold in the country. The program is intended for the treatment of patients in special cases where conventional treatments have failed.
Health Canada verified this information in a statement provided to Mugglehead.
PharmAla recently established a joint venture (JV) with Vitura Health Limited (ASX: VIT) to supply MDMA and psilocybin for medicinal use in Australia. The JV company called Cortexa Pty Ltd will be providing the drugs to authorized physicians and for clinical trials.
Medical practitioners in Australia will be able to prescribe those psychedelics for the treatment of certain mental health conditions beginning in July when the country’s Authorized Prescriber Scheme takes effect.
Australia’s Incannex Healthcare Ltd (ASX: IHL) (NASDAQ: IXHL) also ordered MDMA and psilocybin from PharmAla last month for a series of psychedelics clinics in the country. Incannex will be launching the first of those clinics in Melbourne later this year.
PharmAla began providing psilocybin in addition to MDMA when it signed a distribution agreement with Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) last November. Mindset is providing its cGMP psilocybin to PharmAla to be re-sold to clinical researchers.
PharmAla was the first publicly traded company to supply GMP-certified MDMA. Vancouver’s Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) followed suit when it received an amendment from Health Canada permitting it to produce MDMA in addition to psilocybin last August.
PharmAla has seen its share price rise exponentially in recent days, increasing in value by 1,350 per cent over the past six months and 987.5 per cent over the past year.
The company’s shares stayed flat at $0.44 Tuesday on the Canadian Securities Exchange.