by Dr Michael Winlo, Emyria Managing Director
Recently, Emyria released our Phase One clinical trial results for EMD-RX5, an ultra-pure CBD capsule. EMD-RX5 was developed to address multiple unmet needs where our research has shown high-quality CBD to be effective such as the symptoms of psychological distress.
These results were one step on the journey to registering an over-the-counter CBD medication in Australia (at this point, the first of its kind).
The clinical trial tested EMD-RX5 against Epidyolex, a liquid medication, as opposed to the capsule form of EMD-RX5, to see how it measured up in terms of safety, bioavailability and drug delivery profile.
Why did we pick Epidyolex to measure ourselves against?
The answer is simple – we are on a mission to develop products that are registered treatments – i.e. safe, reliable and proven to work.
To date, Epidyolex is the only CBD medicine in the world that’s achieved that in Europe, the USA and Australia (via the EMA, FDA and TGA respectively).
GW Pharma, the producers of Epidyolex, invested years of development and hundreds of millions of dollars to prove Epidyolex was registration-grade.
You don’t create a 190-page document of evidence like this one without putting in the work: LINK
Epidyolex changed the lives of thousands of patients and GW’s achievement was recognised in February of 2021 with a US $7.2b acquisition by Jazz Pharma.
So that’s the standard we want EMD-RX5 to meet, and that’s why the Phase One trial results were so exciting.
By testing our capsule against the only FDA-registered CBD oil, we are ensuring that Emyria’s drug development program is best placed to obtain multiple global registrations.
And EMD-RX5 passed its first test with flying colours.
In the trial, the pharmacokinetic (PK) characteristics of one 150mg dose of EMD-RX5 was compared with one 150mg dose of Epidyolex CBD oil in 12 healthy male and female volunteers.
Each participant received a single dose of EMD-RX5 or Epidyolex followed by a one-week washout, then received the other.
The results demonstrated excellent safety and tolerability, statistically equivalent bioavailability to Epidyolex, higher drug levels 3-8 hours after dosing and less variability in dose between patients, which should enable doctors and patients to use it with confidence.
For us, that path to registration continues. We now move on to a multi-site Australian Phase 3 trial (pending ethics approval) to assess EMD-RX5 as an over-the-counter treatment for a growing challenge – the symptoms of psychological distress.