INSYS Therapeutics, Inc. (INSY) Completes Initial Clinical Study of Dronabinol Inhalation

INSYS Therapeutics, Inc. (INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, recently completed a human proof-of-concept study of dronabinol inhalation using a novel and patented breath-actuated device licensed exclusively from U.K.-based Senzer Ltd.

“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.”

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 indicate that inhaled dronabinol 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. In addition, Cmax with both formulations was similar, despite the considerable difference in doses.

Senzer’s chief executive officer, Alex Hearn, added: “Our proprietary inhalation technology is exclusive and distinct from a nebulizer, as it does not require heat or combustion to deliver therapeutic drug molecules to the distal lung. 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 diverse clinical development program across its pharmaceutical cannabinoids platform. In addition to dronabinol inhalation, the company’s product pipeline also includes cannabidiol (CBD) oral solution, with company-sponsored clinical trials for childhood absence epilepsy (Phase 2), infantile spasms (Phase 3) and Prader-Willi syndrome (Phase 2) underway.

To augment its internal R&D programs, INSYS continues to strategically pursue research collaborations with external partners. For example, the company has established a collaborative partnership with the University of California (UC) San Diego’s Center for Medicinal Cannabis Research (CMRC) to advance the medical science of cannabinoids, with clinical studies of the company’s CBD oral solution in autism and early psychosisplanned to start in 2019.

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.

About Senzer

Senzer Ltd. is a U.K. based innovative inhalation technology company specializing in development and commercialization of therapeutic delivery systems of cannabinoid products, and is developing a pipeline of inhalation products to meet unmet medical needs. Senzer Ltd. is addressing in particular the need for development of inhaled delivery to provide rapid onset without heat, combustion or electronics to deliver pharmaceutically active cannabinoids, as well as other active pharmaceuticals.

Forward-Looking Statements 

This news release contains forward-looking statements including INSYS Therapeutics’ (i) belief regarding the potential for  dronabinol inhalation with Senzer’s device to become a viable therapeutic approach to a variety of conditions, including anorexia in cancer; and (ii) the expectations around its pharmaceutical cannabinoid platform including the belief that its cannabidiol oral solution can become a treatment option for infantile spasms, childhood absence epilepsy and Prader-Willi syndrome, as well as autism and early psychosis. These forward-looking statements are based on management’s expectations and assumptions as of the date of this news release; actual results may differ materially from those in these forward-looking statements as a result of various factors, many of which are beyond our control. These factors include, but are not limited to, risk factors described in our filings with the United States Securities and Exchange Commission, including those factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended Dec. 31, 2017 and subsequent updates that may occur in our Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date of this news release, and we undertake no obligation to publicly update or revise these statements, except as may be required by law.