LONDON, September 25, 2018 /PRNewswire/ --
The physical uptake of pharmaceutical cannabinoids when inhaled
through Senzer's unique respiratory device is more than 50 times
faster than oral delivery, at just a fraction of the dose,
according to data released today under a clinical trial conducted
in the US.
Senzer, a UK-based drug delivery company, reported the success
of a 36-subject pharmacokinetic trial conducted in the US by its
partner, Insys Therapeutics, Inc. a leader in the development,
manufacture and commercialization of pharmaceutical cannabinoids
and spray technology. Insys holds the license to use Senzer's
device to deliver the cannabinoid, Dronabinol, in the US and the
trial is part of its goal to achieve regulatory approval from the
U.S. Food and Drug Administration. Senzer's patented device allows
conversion of cannabinoids into very small particle sizes, and
other research by the Company has shown that this allows delivery
of actives deep into the lung, into the smaller distal passageways.
Unlike other respiratory approaches, such as nebulizers or
mainstream inhalers, Senzer's offering can result in a much more
rapid uptake of the drug, comparable to injectables or IVs.
"These positive results generated by Insys show how our device
can deliver cannabinoids faster and in much smaller doses, which
should be of great benefit for both patients and health
professionals,' Senzer CEO Alex
Hearn said. "Our approach is unique in this exciting sector,
and offers a simple and minimally invasive way to ensure much more
effective delivery of pharmaceutical-grade cannabinoids."
Insys reported the study enrolled 36 subjects and compared a
single 0.35 mg dose of inhaled dronabinol to a single 5.0 mg dose
of oral dronabinol (Marinol capsule). The findings indicated that
inhaled dronabinol, even at just 7% of the oral dose, had a much
faster absorption rate. The difference in Tmax--the time to peak
concentration (Cmax) of drug in blood plasma--was over 50 times
faster with the test product: 2 minutes with the inhaled
dronabinol, compared to 1.53 hours with the oral dronabinol. In
addition, Cmax with both formulations was similar, despite the
considerable difference in doses, Insys reported.
"This pharmacokinetic study provides evidence of our unique
drug-device combination's viability as a mechanism to deliver
dronabinol into the distal lung for rapid systemic absorption,"
said Steve Sherman, senior vice
president of regulatory affairs for INSYS Therapeutics. "Its
completion represents the next step in our clinical development
program for dronabinol inhalation as an investigational product
concept, which has future potential in the treatment of a variety
of conditions, including anorexia in cancer."
About SENZER
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.
About INSYS
INSYS Therapeutics is a specialty pharmaceutical company that
develops and commercializes innovative drugs and novel drug
delivery systems of therapeutic molecules that improve patients'
quality of life. Using proprietary spray technology and
capabilities to develop pharmaceutical cannabinoids, INSYS is
developing a pipeline of products intended to address unmet medical
needs and the clinical shortcomings of existing commercial
products. INSYS is committed to developing medications for
potentially treating anaphylaxis, epilepsy, Prader-Willi syndrome,
opioid addiction and overdose, and other disease areas with a
significant unmet need.