MyDx’s Biopharmaceutical Division has signed an agreement to begin a new clinical trial of its cannabis-based proprietary pain management formula MyDx360 in Israel with an undisclosed contract research organisation.
Planned to be conducted in one of the leading hospitals in the country, the trial will be supervised by the Israeli Ministry of Health.
The randomised and placebo-controlled trial is expected to estimate the efficacy of MyDx360 in patients suffering from chronic low-back pain as a primary objective.
Its secondary objective is to compare additional evidence of efficacy in the patients’ quality of life in terms of sleep, anxiety, and depression.
The trial also aims to validate MyDxEco Smart Dosing Pen, Handheld Tester, and resulting data, as well as validate the efficacy of MyDx360 delivery mechanisms such as the thin film strips used in the study, among others.
MyDx360 pain management formula is based on more than 50,000 pre-clinical, crowd-sourced physiological data-points tracked by MyDx’s Handheld Cannabis Tester and its associated mobile app.
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By GlobalDataMyDx chief medical officer Dr Jessica Peatross said: “Cannabis holds so much promise for various categories of pain.
“I’m personally very excited to pursue follow-on studies that explore the activation of CB1 receptors to treat endometriosis, which is a painful condition that plagues one in ten women in the US today.”
MyDx plans to start the new trial in March and expects to complete it in the third quarter of this year.