The Israeli company Syqe Medical, a developer of a medical cannabis inhaler, said Wednesday that it had received a nod from the Canadian health authorities that will allow the company to market its metered-dose inhaler to patients in Canada.
This is the first approval given by an international regulatory authority to market a precisely dosed cannabis inhaler as a medical product, as well as the first approval to market a product that combines cannabis with a medical device, the company said in a statement, referring to the medical device license (MDL) received from the Canadian regulator.
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 data showed that the medical cannabis treatment offered by Syqe’s inhaler manages to achieve the desired result of pain relief while reducing 90 percent of adverse events, including psychoactive effects, the statement said.
The inhaler enables precise delivery of cannabis at the level of safety and precision of conventional drugs, the company says.
The Canadian market will be a significant boost to Syqe Medical’s business growth strategy, the company said. 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. It is estimated that the market will reach $380 million by 2024, the statement said.
The approval in Canada comes on the heels of the European Regulatory Certification (CE) the company received a few months ago, for the metered-dose inhaler and the disposable cartridges developed by Syqe Medical. The European CE marking approval is valid for both medical cannabis and a variety of new and existing drugs that the company will insert into its cartridges, subject to required regulatory approvals, the company said.
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 firm hopes to start marketing its product in Canada later this year.
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. This allows Syqe Medical’s patients to consume smaller amounts of medical cannabis than patients using other methods such as smoking, who receive an average of a gram of cannabis per day, which contains about 150,000 micrograms of THC, the statement said.
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. Data of patients in Israel who use the inhaler demonstrate a reduction of about 90% of adverse events compared to other methods of cannabis administration such as oil, vaping and smoking, the company said.
“The approval in Canada would not have been possible without the 10 years of technological development and clinical trials, demonstrating that low doses alongside high precision delivery result in the optimal cannabis treatment,” said Perry Davidson, CEO and founder of Syqe Medical. “The usage data in Israel show that patients regain normal life routine, while the treatment reduces the psychoactive effect and undesirable adverse events.”
“Syqe Medical’s technology, developed and manufactured in Israel, is a real Israeli export of a medical-technological device in the cannabis field,” he 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. Eytan Hyam, former director general of Israel’s Health Ministry and Syqe Medical’s executive medical chairman.
The latest approval is an added “seal of quality” for the product, he said.