Specialty pharmaceutical firm INSYS Therapeutics has completed a human proof-of-concept study of dronabinol inhalation using a patented breath-actuated device licensed from Senzer.
Image: INSYS completes new clinical study. Photo: Courtesy of Alicia Solario/FreeImages.com.
INSYS enrolled 36 subjects for the study, which compared a single 0.35mg dose of inhaled dronabinol to a single 5.0mg dose of oral dronabinol (Marinol capsule).
The findings show that dronabinol when inhaled has a faster absorption rate at a fraction of the oral dose.
The difference in Tmax, the time to peak concentration (Cmax) of drug in blood plasma, was shorter with the test product: 2 minutes with the inhaled dronabinol compared to 1.53 hours with the oral dronabinol.
Cmax with both formulations was similar, in spite of the significant difference in doses.
INSYS Therapeutics regulatory affairs senior vice president Steve Sherman said: “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.
“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 CEO Alex Hearn said that the company’s inhalation technology works differently, compared to a nebulizer and it does not require heart or combustion to deliver the drug molecule to the distal lung.
Hearn said: “It has a unique feature that eliminates the necessity for a battery or heating element and the need for users to master hand-breath coordination. The device is activated simply by inhaling.”
INSYS has a clinical development program for its pharmaceutical cannabinoids platform. Besides its dronabinol inhalation, its product portfolio also includes cannabidiol (CBD) oral solution.
Currently, the company is conducting clinical trials for childhood absence epilepsy (Phase 2), infantile spasms (Phase 3) and Prader-Willi syndrome (Phase 2) underway.
Senzer is a UK-based inhalation technology company that specializes in the development of therapeutic delivery systems of cannabinoid products. It is also engaged in the development of pipeline of inhalation products to meet unmet medical needs.