INSYS Therapeutics Completes Initial Clinical Study of Dronabinol Inhalation with Innovative Breath-Actuated Inhaler
September 24 2018 - 5:00AM
INSYS Therapeutics, Inc. (NASDAQ: 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 psychosis planned
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.
CONTACT: |
Corporate
Communications |
Investor
Relations |
|
Joe McGrath |
Jackie Marcus or Chris
Hodges |
|
INSYS Therapeutics |
Alpha IR Group |
|
480-500-3101 |
312-445-2870 |
|
jmcgrath@insysrx.com |
INSY@alpha-ir.com |
|
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