Article by Zachary Keyser, Jerusalem Post
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, marketed by Israeli pharmaceutical giant Teva, 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 certification to market 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.”
The CE approval came with rights to market the product as either a medical or cannabis product, and for a variety of new and existing treatments the company can implement into its medical cartridges.
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.