Israeli microdosing cannabis inhaler receives approval in Canada

The real world data of the trials showed that patients experienced a 90% reduction in adverse effects associated with marijuana use in comparison with other methods such as oil, smoking and vaping

By ZACHARY KEYSER
Syqe Medical inhaler and the cannabis cartridge (photo credit: SYQE MEDICAL)
Syqe Medical inhaler and the cannabis cartridge
(photo credit: SYQE MEDICAL)
Israeli pharma-tech company Syqe Medical received regulatory approval from Canadian health officials to export and sell its microdosing cannabis inhaler on the Canadian market, the company announced on Wednesday.
With Canada's Medical Device License (MDL) Syqe's Metered-Dose Inhaler will be the first microdosing inhaler approved by an international regulatory health authority to be marketed as an official medical product. It is also the first approval for a product that combines both cannabis with a medical device.
The Canadian approval comes not long after Syqe obtained Europe's CE, which marks quality approval, for its inhaler within the European Economic Area, following positive clinical trials at Rambam Medical Center that found microdosing cannabis can be used as an effective pain reliever while avoiding the psychoactive effects of the drug.
“We are proud to have another international medical authority recognize the groundbreaking therapeutic value that the Syqe Medical Inhaler brings to patients," said CEO and founder of Syqe Medical Perry Davidson. "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.
"The usage data in Israel show that patients regain normal life routine, while the treatment reduces the psychoactive effect and undesirable adverse events.”
Along with the CE approval and the clinical trials, Syqe is preparing and promoting that its inhaler and medical  cartridge be marketed into the Israeli Health Basket Services, while also seeking approvals in several other European countries as well as the United States.
Syqe Medical recently conducted trials last year in which they found evidence that inhaling "extremely low and precise doses" of tetrahydrocannabinol (THC) — the principal psychoactive component in cannabis products — can be used as an effective pain reliever while avoiding the "common [psychoactive] side effects" normally associated with cannabis use.
The research team published their findings in the European Journal of Pain, providing the scientific community with the first research-based evidence that microdosing - "the process of using extremely low doses of active drug compounds to treat various conditions" - can actually be applied to medical cannabis solutions.
The real world data of the trials showed that patients experienced a 90% reduction in adverse effects associated with marijuana in comparison to other administration methods such as oil, smoking and vaping
The study showed that the optimal dose to effectively reduce pain is around 500 micrograms of THC, where patients consume 3-4 inhalations per day and still benefit from a lower dose. Typically medical cannabis patients consume one gram of a 15% THC cannabis per day, which in itself contains 150,000 micrograms of THC.

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The Syqe Metered-Dose Inhaler is the world’s first marijuana inhaler capable of delivering botanicals with the same level of safety and precision as conventional drugs. It is "presumed" that the Syqe platform's bioavailability-enhancing technologies and selective dosing capabilities are behind the success of the trials.
The evidence provided in the Syqe research team's findings could lead the way to the standardized use of applying cannabis inhalation to therapeutic medical solutions, more or less due to the fact the administering method is able to stave off many of the psychoactive effects that tend to accompany marijuana use, which many believed to be an unavoidable side effect with treatment.
Until now, pain relief from medical cannabis has been delivered via edibles; inhaling smoke; or through commercial inhalers or vape pens. None of those, however, provide reliable or accurate doses.
In the edible form, effectiveness often depends on what users ate a few hours before, while the quantities of active ingredients inhaled from smokeable cannabis products have generally been unknown. So, in the absence of precise dosing, cannabis could not be prescribed as a standard medical treatment, causing difficulties for patients and the physicians who treat them.
Approximately 90% of medical cannabis consumers worldwide use the drug by inhalation, and the Syqe inhaler allows them to receive the optimal dose for their condition, in order to alleviate suffering in the most efficient way possible.
“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 Syqe Medical’s Executive Medical Chairman Dr. Eytam Hyam, who formerly served as the director-general of the Health Ministry. "But more importantly, it is another seal of quality, adding to the existing approvals received by Israeli and global regulators, to the innovativeness and effectiveness exemplified by the company’s technology."
Judy Siegel-Itzkovich contributed to this report.


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