LONDON, Sept. 17, 2019 /CNW/ -- Senzer Pharmaceuticals has been granted a CE Mark that certifies its inhaler as a medical device, allowing it to now be available for patients in Europe for the 'safe and effective delivery of pharmaceutical cannabinoids.'
The Class IIa Medical Device approval is the first-ever in the cannabinoid space and clears the way for the UK-based Company to supply the UK in the unlicensed medicines category known as 'Specials'. Senzer will now advance its plans to launch this year in the UK and other leading European territories.
'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,' said Senzer CEO Alex Hearn. 'We believe with our inhaler we can provide answers to some of these key questions.'
To ensure consistency, Senzer's breath-activated inhaler delivers synthetic cannabinoids, all manufactured to a pharmaceutical standard. Development work to date has focused on the cannabinoids CBD and THC, and the Company intends to formulate using specific CBD/THC ratios, giving medical professionals great flexibility to treat patients.
The Senzer inhaler deploys cannabinoids from a pressurised cannister, ensuring these highly reactive elements are kept in an inert, stable state. A patient's breath activates the device, allowing inhalation of the actives in a fine mist that goes deep into the lung, giving a quick uptake at a lower dosage. The device allows patients to control their dosing and the Company has data to show comparability to the uptake from injections or IVs. The Company believes its platform holds considerable advantages over other means of ingestion, such as oral, as well as other respiratory offerings, such as vaping.
Senzer Quality Director Lester Gleeson said the CE Mark approval was a joint project with the Company's manufacturing partner, Europlaz. The approval describes the device as being used for the 'safe and effective delivery of pharmaceutical cannabinoids,' and he said the approval was a significant milestone in Senzer's clinical development strategy.
'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,' Mr Gleeson said. 'This will in turn inform our clinical trial programme as we work to develop fully licensed medicines.'
SENZER Ltd. is a U.K.-based inhalation technology company specializing in the development and commercialization of therapeutic delivery systems of cannabinoid products, and it is developing a pipeline of inhalation and delivery products to meet unmet medical needs. Senzer's platform is based around a patented device that allows swift and effective inhaled delivery of cannabinoids, as well as other active pharmaceuticals.