Senzer Pharmaceuticals said that it plans to launch its cannabinoid inhaler in the UK and elsewhere in Europe by the end of 2019 now that the device has received Class IIa Medical Device approval for the “safe and effective delivery of pharmaceutical cannabinoids.” The company said that in the UK it planned to supply unlicensed products in the “Specials” category.
Senzer has previously said that it believes it is the first company to receive ISO 13485:2016 certification for design and development of a pharmaceutical-grade cannabinoid delivery device. The inhaler is being manufactured by Europlaz.
The breath-activated cannister-based SiDD (Systemic inhaled Delivery Device), which allows the patient to control dosing, has also won several design awards. Earlier this year, the company announced that the device had won an iF Design Award, and in 2018, the inhaler won a Good Design Award.
In July 2018, the company announced plans for launches of its Cannafen cannabidiol inhaler and the Candex dronabinol inhaler. Other products include cannabidiol/dronabinol combinations.
Senzer CEO Alex Hearn commented, “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. We believe with our inhaler we can provide answers to some of these key questions.”
Senzer Quality Director Lester Gleeson added, “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. This will in turn inform our clinical trial program as we work to develop fully licensed medicines.”
Read the Senzer press release.
