- Emyria’s (EMD) CBD product, EMD-RX5, has shown “excellent safety and tolerability” from a phase one trial
- The trial compared equal doses of the EMD-RX5 capsule with the Epidyolex CBD oil, the sole CBD-only medicine registered with the TGA and FDA, in 12 healthy adults
- Emyria says its drug showed no adverse effects, can deliver sustained CBD levels hours after dosing and can deliver twice the bioavailability of other plant-derived CBD products
- Emyria will advance phase three clinical trials to support a TGA registration of EMD-RX5
- Company shares are down 5 per cent to trade at 28.5 cents at 10:50 am AEST
Emyria (EMD) has reported positive data from a phase one trial of its EMD-RX5 “ultra-pure” CBD drug.
The study compared the pharmacokinetic characteristics of one 150mg dose of the EMD-RX5 CBD capsules with one 150mg dose of Epidyolex CBD oil in 12 healthy male and female participants between the ages of 18 and 65.
Epidyolex CBD oil is the sole CBD-only medicine registered with the Australian Therapeutic Goods Administration (TGA) and the US Food and Drug Administration (FDA).
Each volunteer received one dose of EMD-RX5 or Epidyolex followed by a one-week “washout” before receiving the alternative dose form.
Emyria hopes to gain TGA approval for EMD-RX5 to be available in Australia as an over-the-counter (OTC) treatment to help with psychological distress.
According to the company, EMD-RX5 showed “excellent” safety and tolerability with no gastrointestinal discomfort or notable adverse effects at the test dose of 150mg.
The study also showed EMD-RX5 delivers higher CBD exposure three to eight hours after dosing which means CBD levels are sustained for longer.
Further, the drug was shown to deliver twice the bioavailability compared to other plant-derived CBD products in Australia with published pharmacokinetics data.
Managing Director Dr Michael Winlo said the data shows Emyria has developed a unique product with “excellent safety and tolerability and highly favourable drug delivery and absorption characteristics.”
“These results confirm EMD-RX5’s suitability as a multi-indication treatment of chronic
conditions and support Emyria’s initial OTC drug registration program targeting the symptoms of psychological distress,” Dr Winlo said.
Emyria will now advance phase three clinical trials to support the TGA registration of EMD-RX5.
Company shares were down 5 per cent to trade at 28.5 cents at 10:50 am AEST.