Australian medical cannabis company Emyria (ASX: EMD) has received the go-ahead for a Phase 3 trial of its over-the-counter cannabidiol formulation.
In March we reported emryia was preparing for a phase 1 study of its EMD-RX5 formulation, which has been developed to address psychological distress. On Tuesday, the company announced that it had received approval from the Human Research Ethics Committee (HREC) to start a phase 3 clinical trial of EMD-RX5.
So what happened to a phase 2 trial? As we previously mentioned, Emyria stated that it would collect enough real-world data during the Phase 1 trial to skip a Phase 3 study. According to the company, the Phase 1 trial indicated that EMD-RX5 demonstrated excellent safety and tolerability, with no gastrointestinal discomfort or adverse events of concern at the 150 mg test dose. This dosage level is the maximum allowed daily under Australia’s over-the-counter cannabidiol guidelines.
Emryia is one of several companies aiming to be the first, or among the first, to be able to offer an over-the-counter (pharmacy-only) Schedule 3 cannabidiol drug, so this study is particularly important.
“Successful completion of the Phase 3 trial will support registration of EMD-RX5 with the Therapeutic Goods Administration (TGA) as a Schedule 3, over-the-counter (OTC) treatment for symptoms of psychological distress.”
This product is supposed to get a name a little faster if it hits drugstore shelves.
“The initiation of our pivotal Phase 3 trial is an important milestone for Emyria and for the many patients managing symptoms of psychological distress but without a registered over-the-counter treatment option.” said The CEO of Emyria, Dr. Michael Winlow.
Under the phase 3 trial, 300 participants between the ages of 18 and 70 with symptoms of stress and a history of chronic pain will receive one month of treatment with 50 mg of EMD-RX5, 150 mg of EMD-RX5, or matching placebo. The primary objective is to determine the effect of EMD-RX5 treatment on symptoms of psychological distress.
The trial will be conducted at multiple sites, with the first site at the Hatherley Medical Center in Winthrop, Western Australia.
Emyria believes that a successfully registered OTC drug for psychological distress represents a great opportunity for the company to address an important unmet health need. Given the difficult times we live in, that might be an understatement.