Case study: EMD-003
Developing a new cannabinoid formulation for stress, anxiety and depression.
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 27 million antidepressant prescriptions.
Many medications can cause sedation, withdrawal and memory impairment.
Over 50% of patients at Emerald Clinics, our clinic network, 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, clinical studies have been patchy and inconclusive.
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 low-dose cannabinoid palatable
Our experience at Emerald Clinics highlighted a second issue. Even with sufficient evidence to gain regulatory approval for a low-dose cannabinoid treatment for mental health issues, patients were frustrated with traditional oils and droppers.
Patients really want a more 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 for 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. Our registration study of EMD003 shows this model in action.”
Dr Michael Winlo, Managing Director, Emyria
Having prescribed a broad range of products in different dose forms, our Emerald Clinics doctors have a wealth of comparison data to draw on. This includes data generated by prescribing EMD-003 to over 170 patients in a convenient capsule form that patients prefer. The capsule uses special slow-release absorption technology, which enhances efficacy.
Once we have secured registration with our final evidence package (expected to be submitted in the second half of 2021), EMD-003 will help tackle the growing global concern of mental health and, in particular, the symptoms of anxiety, depression and stress.
In addition to our TGA-registration plan, we have designed our EMD-003 registration studies to meet the requirements of other global regulatory bodies. This gives us the ability to subsequently apply for EMD-003 pharmaceutical registration in other major markets and jurisdictions.
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 generates a one-of-a-kind data asset that we use to expedite the development and registration of new treatments and therapies, or find new ways to use conventional ones.
EMD-003 is a case in point for our approach. It proves that our repeatable model generates the clinical-trials-quality data and real-world evidence regulators need to approve novel treatments, making them available to doctors and patients across mainstream healthcare systems worldwide.