INSYS Therapeutics Completes Pharmacokinetics (PK) Study of Intranasal Naloxone for Opioid Overdose
October 03 2017 - 10:07AM
INSYS Therapeutics, Inc. (NASDAQ:INSY) (“INSYS” or “the company”),
announced today that its recently completed pharmacokinetics (PK)
study of the company’s proprietary intranasal naloxone spray
formulation for the treatment of opioid overdose showed favorable
results, similar to those for the current standard of intramuscular
administration of naloxone.
“We believe that an intranasal naloxone spray
formulation represents a potentially valuable alternative to treat
known or suspected opioid intoxication or overdose,” said Steve
Sherman, senior vice president of Regulatory Affairs at INSYS.
“Based on the results of this study, we look forward to working
with the FDA to bring this promising treatment alternative to the
people on the front lines of the opioid crisis.”
Naloxone has been used in opioid overdose
management for more than 40 years. It works by rapidly displacing
the intoxicating opioids from the brain’s opioid receptors,
reversing the clinical signs of opioid overdose if administered
soon enough. Naloxone was first approved in the United States in
1971 as Narcan® injection to reverse opioid intoxication and
overdose. It is currently available in injectable, intranasal
and auto-injector delivery forms.
“We are excited by the data from this study, and we
look forward to working with the FDA on the regulatory path ahead,”
said Saeed Motahari, president and chief executive officer of
INSYS. “While our R&D focus has shifted to pharmaceutical
cannabinoids, a significant part of continuing efforts in investing
and developing our naloxone program relate to the social
responsibility associated with this type of product. Pending a
successful NDA filing in 2018 and subsequent FDA approval, our
intention is to launch our intranasal naloxone spray at an
affordable price.”
This investigational product is the first from
INSYS to use an intranasal spray technology. Other pipeline product
candidates from the company that use this technology include
epinephrine nasal spray for anaphylaxis reaction and rizatriptan
nasal spray for migraine.
About INSYSINSYS 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 intending
to address unmet medical needs and the clinical shortcomings of
existing commercial products. INSYS currently markets SUBSYS®
(fentanyl sublingual spray), CII, and SYNDROS® (dronabinol) oral
solution, CII, a proprietary, orally administered liquid
formulation of dronabinol. INSYS is committed to developing
medications for potentially treating addiction to opioids, opioid
overdose, epilepsy, and other disease areas with a significant
unmet need.
SUBSYS® and SYNDROS® are trademarks of INSYS
Development Company, Inc., a subsidiary of INSYS Therapeutics,
Inc.
NOTE: All trademarks and registered trademarks are
the property of their respective owners.
Forward-Looking
Statements This news release contains forward-looking
statements including regarding (i) our belief that an intranasal
naloxone spray formulation represents a potentially valuable
alternative to treat known or suspected opioid intoxication or
overdose and (ii) our intention is to launch our intranasal
naloxone spray at an affordable price. 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, 2016 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:
Media RelationsJoe McGrathSenior Director,
Corporate CommunicationsINSYS
Therapeutics480-500-3101jmcgrath@insysrx.com
Investor RelationsJackie Marcus or Chris
HodgesAlpha IR Group312-445-2870 INSY@alpha-ir.com
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