The SyqeAir Inhaler has been approved by the Therapeutic Goods Administration (TGA) and included in the Australian Register of Therapeutic Goods (ARTG).
Israel-based Syqe Medical produces the technology, which is supplied in Australia by sponsor and distribution partner Novachem. It was shortlisted in the innovation category at the Cannabiz Awards in June.
Syqe said the device is “the first and only metered-dose cannabis inhaler to obtain ARTG approval in Australia”.
Designed to administer low, metered, and consistent doses of medicinal cannabis by inhalation, it has demonstrated safety and efficacy in three clinical trials as well as via real-world settings, according to the firm.
Syqe said the evidence showed patients can experience a fast reduction in the intensity of pain, improved sleep and quality of life, with minimal psychoactive adverse events compared to other dosage forms.
The product is comprised of the inhaler and a pre-loaded cartridge containing 60 uniform doses of pharmaceutical-grade, full-spectrum raw cannabis flower cultivated under EU-GMP conditions by Bedrocan.
Syqe recently signed an agreement with the Israeli Ministry of Defence to provide the inhaler to all its veterans suffering from chronic pain and PTSD who need medicinal cannabis treatment.
CEO Hagit Kamin said: “Receiving ARTG approval in Australia is a significant achievement for our company.
“We are excited to collaborate with healthcare professionals and organisations in Australia to expand access to the SyqeAir Inhaler, enabling patients to benefit from reliable and consistent medicinal cannabis treatment.”
Director of global sales Jacob Vogel added: “This is another big milestone in our journey to bring medicinal cannabis treatment into 21st century medical standards, providing patients and healthcare professionals [with] a safer clinical option.”
Novachem medical products manager Andrew Heath said registration was a “landmark achievement for both Novachem and Syqe Medical”.
He added: “The SyqeAir Inhaler represents a significant step forward in the medicinal cannabis industry, offering patients and healthcare professionals a safer, consistent and easy-to-use delivery system.
“Additionally, this approval opens up new reimbursement opportunities, making this advanced treatment more accessible to patients who need it most.
“We are very excited about the further opportunities to engage with doctors, clinics and pharmacies with the device and will be exhibiting at the upcoming General Practice Conference and Exhibition in Melbourne in November.”