London (ots/PRNewswire) - 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
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
'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.
Digital press kit: http://www.ots.at/pressemappe/PR131299/aom
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