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."
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.
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.