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- Emyria (EMD) is looking to register its EMD-003 cannabinoid medicine product with Australia’s Therapeutic Goods Administration (TGA)
- In the first half of the year, the company will conduct a pivotal clinical trial aimed at reducing symptoms of anxiety, depression and stress
- Emyria will utilise data that its subsidiary, Emerald Clinics, has compiled since the TGA down-scheduled low-dose CBD to Schedule 3
- In the second half of the year, the company hopes to complete a final evidence package to support TGA registration
- Emyria is down 4 per cent with shares trading at 9.6 cents
Emyria (EMD) is looking to register its EMD-003 product with Australia’s Therapeutic Goods Administration (TGA).
EMD-003 is the company’s first cannabinoid-based medicine that has been developed after an analysis of data collected by its subsidiary, Emerald Clinics.
Emerald Clinic doctors provide long-term care for patients with unresolved conditions. By monitoring these patients, the company has compiled unique data that gives insights into formulations and dose responses.
“By also taking our time with every patient and using our bespoke digital health platform, which also incorporates remote monitoring, we have built a high-quality and one-of-a-kind clinical data asset,” Managing Director Dr Michael Winlo said.
At this stage, only one cannabinoid-based medicine has been registered with the TGA, as all others are only available through special access schemes, authorised prescribers or clinical trials.
Notably, the TGA announced in December last year that it would allow low-dose CBD to be registered as a Schedule 3 medication. Ultimately, this ruling allows patients to buy registered CBD products over-the-counter.
Following the ruling, Emyria analysed its data to prepare for planned clinical trials.
In the first half of this year, Emyria plans to begin a registration study for the cannabinoid product which will focus on reducing symptoms of anxiety, depression and stress.
In 2018 and 2019, 4.3 million Australians received mental health-related prescriptions. This includes over 27 million antidepressant prescriptions which are currently the recommended first choice pharmacological treatment for anxiety.
Emyria hopes its upcoming registration program will deliver a new registered medicine which will treat patients suffering from mental health challenges.
“We’re excited to pursue the pivotal registration study of EMD-003 with the TGA in 2021 and help tackle the growing global concern of mental health and, in particular, the symptoms of anxiety, depression and stress,” he said.
The company is also preparing a final evidence package to support TGA registration and this is expected to be completed in the second half of the year.
Emyria is down 4 per cent with shares trading at 9.6 cents in early afternoon trade.
