Case Studies

Program: EMD-RX5


Mental health is a growing global health challenge and notoriously difficult to treat. In Australia, mental health is often cited as the most prevalent chronic health condition, affecting 4.8 million people. That’s over 20% of all Australians.

4.3 million Australians received mental health-related prescriptions (2018-19).
This included 31 million prescriptions for antidepressants.
Many medications can cause sedation, withdrawal and memory impairment.
Over 50% of patients at our clinical network, Emerald Clinics, present with moderate to severe depression, anxiety or stress .

Registered medications reach many more patients and yet roughly one-third of conventional medications for mental health are thought to be ineffective in treating the symptoms of stress, anxiety and depression.

While there has long been strong anecdotal evidence to suggest low-dose medicinal cannabis could be an effective treatment for the symptoms of stress, anxiety and depression, there is a gap in clinical-grade evidence to demonstrate its safety and efficacy

The first problem: The need for solid clinical evidence

In December 2020 the TGA ruled that low-dose (<150mg) CBD could be registered as a schedule 3 ‘pharmacist only’ medication.

However, the TGA quite rightly stressed that all applications would require high-quality dose-, product- and indication-specific clinical evidence for registration.

The second problem: Making a reliable low-dose cannabinoid palatable

Our experience highlighted a second issue. Even with sufficient evidence to gain regulatory approval for a low-dose cannabinoid treatment for mental health issues, many of the CBD products are poorly absorbed by the body and patients were frustrated with traditional oils and droppers.

Patients really want a more reliable, convenient, palatable dose form.

With our CBD experience and a significant patient cohort experiencing mental health issues, we saw a unique opportunity to register our own low-dose cannabinoid medicine to improve the symptoms of stress, anxiety and depression.

After conducting an in-depth analysis of our own data, published literature and patent landscape, we filed unique IP covering the use of specific doses of CBD covering the TGA’s 150mg threshold for a set of medical indications and patient cohorts.

“Because we take our time with every patient and use our dynamic real-world evidence platform to gain invaluable clinical insights, we’re able to focus on achieving the best outcomes for each individual patient."

“It also means we have a high-quality, one-of-a-kind clinical data asset that provides invaluable real-world evidence and intellectual property that can accelerate drug registration programs.”

Dr Michael Winlo, Managing Director, Emyria

Drawing on our Real-World Evidence platform, we have designed a new Ultra-Pure capsule CBD medication, EMD-RX5, which is on an accelerated journey towards registration.

Capsule image

In less than 12 months, Emyria has developed a proprietary Ultra-Pure CBD capsule and completed both animal and human trials.

Our Phase 3 trial, a major step towards registration, began in late 2022 with a view to being completed in 2023. This would be our first, proprietary medication to complete Phase 3 trials and then submit for registration in Australia, as well as international markets.

In a comparison trial with Epidyolex, the only TGA and FDA-registered CBD medicine on the market, EMD-RX5 demonstrated:

- Slower-release profile (supports once to twice daily dosing)
- Lower dose variability between patients (more consistent drug exposure between patients)
- Lower metabolite measures (may contribute to improved long-term safety profile)

Further, our use of Ultra-Pure CBD contains no THC or other impurities and can be manufactured at a fraction of the environmental impact of alternatives.

Our independent clinics and proprietary data management tech have enabled us to provide novel treatment options and hope for patients who have exhausted all other options.

It’s a model that allows us to provide truly personalised care based on deeper patient knowledge and insights. This deep care also generates a one-of-a-kind data asset that can expedite the development and registration of new treatments and therapies, or find new ways to use conventional ones.

EMD-RX5 demonstrates the effectiveness of our approach. It proves that our repeatable model generates clinical-trials-quality data and real-world evidence that can guide innovative drug development. We now look forward to working with regulators around the world to approve our treatments so they can become available to doctors and patients across mainstream healthcare systems worldwide.

Tap into our clinical care, real-world data and registration expertise.

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