The Therapeutic Goods Administration (TGA) has approved the SyqeAir Inhaler and added it to the Australian Register of Therapeutic Goods (ARTG).
The technology is developed by Israel-based Syqe Medical and distributed in Australia through sponsor and distribution partner Novachem. The device was shortlisted in the innovation category at industry awards in June.
Syqe describes the device as “the first and only metered-dose cannabis inhaler to obtain ARTG approval in Australia”.
Built to deliver low, measured, and consistent doses of medicinal cannabis via inhalation, the inhaler has shown safety and efficacy across three clinical trials and in real-world settings, according to the company.
According to Syqe, the evidence indicates that patients can achieve rapid reductions in pain intensity, better sleep, and improved quality of life, with fewer psychoactive side effects than those associated with other dosage forms.
The product consists of the inhaler and a pre-loaded cartridge holding 60 uniform doses of pharmaceutical-grade, full-spectrum raw cannabis flower grown by Bedrocan under EU-GMP conditions.
Syqe recently entered into an agreement with the Israeli Ministry of Defence to supply the inhaler to veterans dealing with chronic pain and PTSD who require 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.”
