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Monday, Mar 27, 2023
Mugglehead Magazine
Alternative investment news based in Vancouver, B.C.


PharmAla Biotech signs agreement to sell clinical-grade MDMA in Australia

Companies are running more MDMA and psilocybin trials after the Australian drug regulation changes

PharmAla Biotech signs agreement to sell clinical-grade MDMA in Australia
Photo by Artem Podrez via Pexels.

PharmAla Biotech Holdings Inc. (CSE: MDMA) has signed an agreement to sell a batch of its patented MDMA to an Australian drug developer after the country rescheduled the drug to be used as medicine.

On Tuesday, the company announced that it entered into a sales agreement with Emyria Limited (ASX: EMD) (ASX: EMD) for its clinical-grade, GMP-certified MDMA LaNeo. PharmAla Biotech has also submitted a trademark application for the drug in Australia.

The company is the only manufacturer and exporter of clinical-grade MDMA at the moment and the only company in the world that offers both EU-GMP MDMA and EU-GMP Psilocybin.

Emyria is a drug development company focused on data, clinical care and delivering clinical insights. The company announced the expansion of its MDMA programs last week to establish a network of clinical partners, develop a supply chain for the drugs, identify GMP-MDMA suppliers and develop a Phase 2B clinical trial protocol for MDMA-assisted therapy.

“We currently have a historic opportunity before us: to not only supply customers with high-quality EU-GMP API and drug products, but also to build one of the preeminent psychedelics operations in Australia – the country leading the world with regulations to support treatment,” PharmAla Biotech’s COO Shane Morris said.

“PharmAla has worked hard to develop world-class excellence in manufacturing and regulatory compliance. We look forward to the opportunity to share our product data not only with our partners and clinicians but with the TGA in future meetings.”

Read more: Australia re-classifies MDMA and psilocybin to be prescribed as medicine

Read more: Mind Medicine Australia receives AUD$1M grant for psychedelic research

PharmAla’s drug API is GMP-certified and is available to companies or people who have permission to use it for research or as an exception. The company can also export it to be used by clinical trial practitioners globally, subject to the issuance of import and export permits.

PharmAla’s research and development unit has also begun preclinical research into two patented Novel Chemical Entities (NCEs) based on MDXX class molecules, with proof-of-concept research currently being done at the University of Arkansas Medical School.

“Forward-looking companies are already moving to supply their clinical operations following the TGA’s regulatory change that will take effect on July 1st,” PharmAla Biotech CEO Nick Kadysh said.

“While this is a nascent industry, we are committed to responsibly supplying our customers as they develop operational capacity,” said Kadysh, adding that the company has already been running three different clinical trials for its LaNeo MDMA molecule.

“We’re very pleased that, just 10 days after the change was announced, we’re in advanced discussions with a number of interested parties, and have already closed a new purchase order.”

Read more: Optimi Health submits clinical trial application after developing proprietary MDMA drug

Read more: PharmAla Biotech gets Health Canada approval to export large MDMA shipment to the U.K.

Producers running MDMA and psilocybin trials after Australian regulation changes

On February 3, the Australian Government’s Therapeutic Goods Administration announced 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.

Creso Pharma Limited (ASX:CPH) (FRA:1X8)’s subsidiary Halucenex Life Sciences Inc. –located in Windsor, Nova Scotia– announced last week it may register its synthetic psilocybin formulation for the Australian market following recent regulatory changes.

Halucenex is currently running a Phase II clinical trial to test psilocybin as a treatment for PTSD which expects will provide a strong foundation for registering the company’s Lucenex-branded synthetic psilocybin product as a potential treatment option in Canada and Australia. The company is already a licenced psilocybin supplier under Health Canada’s Special Access Program in Canada. 

Vancouver-based Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) has submitted a clinical trial application after successfully producing the first batch of the patented MDMA variety  OPTI-MHCL. Optimi received permission from Health Canada to manufacture and distribute MDMA in August last year.

Optimi said the new drug will potentially be used for clinical studies and treating patients authorized to access the psychedelic through Health Canada’s Special Access Program and Australia’s new Authorized Prescriber Scheme.


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