Australian alternative medicine company Emyria (ASX: EMD) is getting on the front foot ahead of regulatory changes for the supply of MDMA, announcing today it has secured clinical-grade supplies of the drug for patients.
With the Therapeutic Goods Administration (TGA) having earlier this month announced that psychiatrists will soon be able to prescribe psychedelic drugs MDMA and psilocybin to treat patients suffering from post-traumatic stress disorder (PTSD) and depression, Emyria is looking to leverage its own research ahead of the July 1 regulatory changes.
The company says it has secured a supply of clinical-grade MDMA for a cohort of more than 70 patients through Canadian manufacturer PharmAla. Distribution will be facilitated by Mind Medicine Australia - a registered charity.
According to Emyria, the procurement of patient-ready MDMA is ‘highly challenging’ due to strict Good Manufacturing Practice (GMP) standards and limited global manufacturers, of which PharmAla is one of the only firms able to export GMP-grade MDMA.
Once received, Emyria will make the drug available to partner psychiatrists with ‘Authorised Prescriber status’ or under ethics-approved clinical trials.
“Emyria has expertise delivering treatments to patients with substances listed under Schedule 8 and 9 while generating Real-World Evidence to support care model improvement and novel drug development,” Emyria managing director Dr Michael Winlo said.
“To support its partners to provide MDMA-assisted therapy from July 1st, Emyria has secured a short-term supply of patient-ready MDMA that can be provided within a comprehensive care model (EMDMA-001) together with appropriately trained and reputable care providers.
“Our approach of participating in care delivery also supports our analogue program.”
When the TGA’s regulatory changes come into effect Australia will be one of the first countries in the world to allow patient access to MDMA-assisted therapy - a leading position that Emyria has been embracing.
Last week, Emyria told investors that it was ‘uniquely positioned’ to take advantage of the TGA’s decision and said it would help commercialise MDMA-assisted therapies once the new regulations come into effect.
The company added that the rescheduling of MDMA also opens a pathway to registration and reimbursement for Emyria’s MDMA-inspired compounds, which are being developed with the University of Western Australia for a range of neuropsychiatric disorders.
Shares in the company, as well as psilocybin player Little Green Pharma’s (ASX: LGP) securities, spiked as a result. For Emyria, these highs have continued today - up 12.24 per cent to 28 cents per share at the time of writing.
Get our daily business news
Sign up to our free email news updates.
Help us deliver quality journalism to you.
As a free and independent news site providing daily updates
during a period of unprecedented challenges for businesses everywhere
we call on your support