The Israeli firm Syqe Medical, a developer of a medical hashish inhaler, stated Wednesday that it had acquired a nod from the Canadian well being authorities that can enable the corporate to market its metered-dose inhaler to sufferers in Canada.
That is the primary approval given by a world regulatory authority to market a exactly dosed hashish inhaler as a medical product, in addition to the primary approval to market a product that mixes hashish with a medical gadget, the corporate stated in an announcement, referring to the medical gadget license (MDL) acquired from the Canadian regulator.
The approval was obtained primarily based on medical trials carried out by the corporate on the Rambam Well being Heart in Haifa, Israel, and on knowledge from sufferers utilizing the product within the Israeli market. The information confirmed that the medical hashish remedy supplied by Syqe’s inhaler manages to attain the specified results of ache reduction whereas decreasing 90 % of adversarial occasions, together with psychoactive results, the assertion stated.
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The inhaler permits exact supply of hashish on the degree of security and precision of standard medication, the corporate says.
Illustrative picture of somebody smoking hashish. (Tunatura; iStock by Getty Photographs)
The Canadian market can be a major increase to Syqe Medical’s enterprise progress technique, the corporate stated. The medical hashish market in Canada included on the finish of 2020 some 370,000 licensed medical hashish sufferers and a complete of over 5.8 million Canadians affected by persistent ache. It’s estimated that the market will attain $380 million by 2024, the assertion stated.
The approval in Canada comes on the heels of the European Regulatory Certification (CE) the corporate acquired a number of months in the past, for the metered-dose inhaler and the disposable cartridges developed by Syqe Medical. The European CE marking approval is legitimate for each medical hashish and quite a lot of new and current medication that the corporate will insert into its cartridges, topic to required regulatory approvals, the corporate stated.
Primarily based on the CE approval, medical trials and affected person references, Syqe Medical is looking for to introduce the inhaler together with the medical hashish cartridges into the Israeli “basket” of well being companies coated by its healthcare organizations, and on the identical time, is engaged on receiving approvals in a number of European nations. The agency hopes to start out advertising its product in Canada later this yr.
Perry Davidson, CEO and founding father of Syqe Medical (Eyal Izhar)
The latest medical trial carried out by the corporate at Rambam Hospital, which was revealed within the European Journal of Ache, confirmed that the optimum dose that balances ache reduction with a discount of adversarial and psychoactive results — the “therapeutic window” — beneficial for sufferers receiving hashish by inhalation is merely 500 micrograms of THC, the principle psychoactive element of hashish. This permits Syqe Medical’s sufferers to eat smaller quantities of medical hashish than sufferers utilizing different strategies corresponding to smoking, who obtain a mean of a gram of hashish per day, which incorporates about 150,000 micrograms of THC, the assertion stated.
The Rambam research additionally confirmed that extraordinarily low doses of hashish deliver concerning the desired results whereas avoiding the “high” feeling that accompanies using hashish, which drastically contributes to every day functioning, high quality of life and security, the assertion added. Knowledge of sufferers in Israel who use the inhaler show a discount of about 90% of adversarial occasions in comparison with different strategies of hashish administration corresponding to oil, vaping and smoking, the corporate stated.
“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,” stated Perry Davidson, CEO and founding father 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,” stated Dr. Eytan Hyam, former director basic of Israel’s Well being Ministry and Syqe Medical’s government medical chairman.
The most recent approval is an added “seal of quality” for the product, he stated.