Analysis of an Australian patient registry indicates medical cannabis administered orally is generally providing improvements in well-being, mental health, severity of pain and physical function.
The analysis is based on nearly 4,000 patients in the Australian Emyria Clinical e-Registry (AECeR), which Emyria says is the largest of its type in the world. It has monitored patients taking prescribed oral medical cannabis for up to 24 months.
On the safety side of things, 1,477 patients (37.3 percent) reported experiencing at least one adverse event attributed to treatment. Sedation/sleepiness and dry mouth were the most commonly reported events, and in 68.2 percent and 79.9 percent of these events (respectively) the issues were assessed as “mild”. Overall, there were 77 “severe” events requiring dose adjustment or cessation, but without lasting impacts. There were just two serious events – hallucination and mania.
In terms of efficacy, some of the highlights:
- The RAND SF36 scores significantly improved for over two years across all of the measured parameters.
- Insomnia Severity Score mean difference reduction was 5 points – that was maintained over two years.
- Brief Pain Inventory across the entire cohort indicated a reduction of approximately 25% for pain interference and 24% for pain severity; maintained for 2 years
Among the Emyria-affiliated researchers’ conclusions:
“This large Australian longitudinal cohort registry of cannabis naïve, complex chronic disease patients treated with oral MC for over 24 consecutive months, demonstrates safety of oral generic medicinal cannabis, and demonstrated oral MC improves patient and clinician reported impact of pain, sleep and well-being.”
The full study report has been published in the peer-reviewed Public Library of Science One Journal.
Emyria is one of the companies vying to be among the first to get a Schedule 3 (Pharmacist Only) low-dose cannabidiol product across the line in Australia. It was given the go-ahead for a phase 3 trial of its over-the-counter cannabidiol formulation in August this year. The target indication for its prospective S3 product at that point was psychological distress.
Commenting on the study, the company said:
“Emyria is committed to using this evidence to inform the development of high-quality, pharmaceutical-grade cannabis medications so they can become registered treatments and help a large number of patients.”