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- Emyria’s CBD (EMD) product, EMD-RX5, has been shown to have “excellent safety and tolerability” from a Phase 1 trial.
- The trial compared equal doses of the EMD-RX5 capsule with Epidyolex CBD oil, the only CBD-only drug registered with the TGA and the FDA, in 12 healthy adults.
- Emyria says its drug showed no side effects, can deliver sustained CBD levels hours after dosing, and can offer twice the bioavailability of other plant-derived CBD products.
- Emyria to Advance Phase Three Clinical Trials to Support EMD-RX5 TGA Record
- Shares of the company fell 5% to 28.5 cents at 10:50 a.m.
Emyria (EMD) has reported positive data from a phase 1 trial of its “ultra-pure” CBD drug EMD-RX5.
The study compared the pharmacokinetic characteristics of a 150 mg dose of EMD-RX5 CBD capsules with a 150 mg dose of Epidyolex CBD oil in 12 healthy male and female participants aged 18 to 65 years.
Epidyolex CBD oil is the only CBD-only drug registered with the Australian Therapeutic Products Administration (TGA) and the US Food and Drug Administration (FDA).
Each volunteer received a dose of EMD-RX5 or Epidyolex followed by a one-week “wash” before receiving the alternate dose form.
Emyria hopes to get TGA approval to make EMD-RX5 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 without gastrointestinal discomfort or noticeable adverse effects at the 150 mg test dose.
The study also showed that EMD-RX5 offers a higher CBD exposure of three to eight hours after dosing, which means that CBD levels are maintained for longer.
In addition, the drug was shown to offer twice the bioavailability compared to other plant-derived CBD products in Australia with published pharmacokinetic data.
CEO Michael Winlo said the data shows that Emyria has developed a unique product with “excellent safety and tolerability characteristics and very favorable drug delivery and absorption characteristics.”
“These results confirm the suitability of EMD-RX5 as a multi-indication treatment for chronic
conditions and support Emyria’s initial OTC drug registration program aimed at symptoms of psychological distress, ”Dr. Winlo said.
Emyria will now advance phase three clinical trials to support the EMD-RX5 TGA registry.
Shares of the company fell 5 percent to 28.5 cents at 10:50 a.m. EAST.
