The approval was obtained based on clinical trials conducted by the company at the Rambam Health Center in Haifa, Israel, and on data from patients using the product in the Israeli market.
The medical cannabis market in Canada included at the end of 2020 some 370,000 licensed medical cannabis patients and a total of over 5.8 million Canadians suffering from chronic pain.
The approval in Canada comes on the heels of the European Regulatory Certification the company received a few months ago, for the metered-dose inhaler and the disposable cartridges developed by Syqe Medical.
Based on the CE approval, clinical trials and patient references, Syqe Medical is seeking to introduce the inhaler along with the medical cannabis cartridges into the Israeli “basket” of health services covered by its healthcare organizations, and at the same time, is working on receiving approvals in several European countries.
The most recent clinical trial conducted by the company at Rambam Hospital, which was published in the European Journal of Pain, showed that the optimal dose that balances pain relief with a reduction of adverse and psychoactive effects — the “therapeutic window” — recommended for patients receiving cannabis by inhalation is merely 500 micrograms of THC, the main psychoactive component of cannabis.
The Rambam study also showed that extremely low doses of cannabis bring about the desired effects while avoiding the “high” feeling that accompanies the use of cannabis, which greatly contributes to daily functioning, quality of life and safety, the statement added.
“The approval received from the Canadian health authorities, and the initiation of the marketing and sales in the Canadian market, are in fact a validation of Syqe Medical’s business and regulatory strategy, and alongside the sales in Israel, Syqe Medical is developing and making its way into global markets,” said Dr.
But as the journalism we do is costly, we invite readers for whom The Times of Israel has become important to help support our work by joining The Times of Israel Community.