Senzer Pharmaceuticals said yesterday that it has received the CE Mark for its cannabinoid inhaler.
London-based Senzer said the Class IIa medical device approval, obtained in a joint project with manufacturing partner Europlaz, is the first-ever granted in the cannabinoid space and will allow the company to accelerate its plans to launch in the UK and other European countries this year.
The breath-activated inhaler is designed to deliver synthetic cannabinoids as a fine mist from a pressurized canister, releasing into the lungs. Senzer said the device will allow patients to control dosing as well.
The company said development up to this point has focused on CBD and THC delivery, and it plans to use specific rations of the chemicals to give professionals flexibility in treatment.
“Many patients have been approaching their doctors to seek cannabinoid treatment, and doctors have understandably been wanting clarity on which cannabinoids are available, how to ensure a controlled dose, and whether the actives are validated and supported by clinical evidence,” CEO Alex Hearn said in a news release. “We believe with our inhaler we can provide answers to some of these key questions.”
“Launching into the Specials arena will give us some real insight into what conditions people are requesting treatment for, and to evaluate which may be the most optimal formulations for these conditions,” added quality director Lester Gleeson. “This will, in turn, inform our clinical trial program as we work to develop fully licensed medicines.”