INSYS Therapeutics Files New Drug Application (NDA) for Buprenorphine Sublingual Spray with FDA
September 29 2017 - 9:00AM
In advancing its pipeline of innovative medicines, INSYS
Therapeutics, Inc. (NASDAQ:INSY) (“INSYS” or “the company”),
announced today that it filed a New Drug Application (NDA) for a
novel formulation of buprenorphine as a sublingual spray for the
management of moderate-to-severe acute pain with the U.S. Food and
Drug Administration (FDA).
“We believe that buprenorphine sublingual spray represents a
promising new treatment option that will address an unmet
need for physicians and patients who would like an alternative to
the traditional opioids used to treat their moderate-to-severe
acute pain,” said Steve Sherman, senior vice president of
Regulatory Affairs at INSYS. “As a partial mu-opioid agonist, it is
believed that buprenorphine has less abuse potential than other
opioids frequently used in this indication and is thought to have a
ceiling effect for respiratory depression.”
According to published research, buprenorphine’s other potential
advantages as a treatment for acute pain include less cognitive
impairment and less constipation compared to full opioid agonists.
This research suggests that buprenorphine possesses unique
pharmacological properties that may make it a safe and efficacious
alternative to traditional opioids, especially outside of a
hospital setting.
“Our NDA for buprenorphine sublingual spray marks another major
milestone for the company’s R&D pipeline,” said Saeed Motahari,
president and chief executive officer of INSYS. “This submission to
the FDA supports our goal of filing one NDA every year for the next
five years as we execute on our collective vision and expand our
product portfolio.”
In addition to buprenorphine sublingual spray, INSYS is also
developing treatments for a variety of conditions other than pain,
including synthetic cannabidiol (CBD) for two types of pediatric
epilepsy and Prader-Willi syndrome; dronabinol oral solution for
anorexia associated weight loss in cancer patients;
buprenorphine/naloxone sublingual spray for opioid dependence;
naloxone nasal spray for opioid overdose; 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 our
belief that (i) buprenorphine sublingual spray represents a
promising new treatment option that will address an unmet
need for physicians and patients who would like an alternative to
the traditional opioids used to treat their moderate-to-severe
acute pain, and (ii) buprenorphine has less abuse potential than
other opioids frequently used in this indication and is thought to
have a ceiling effect for respiratory depression. 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
INSYS THERAPEUTICS, INC. (NASDAQ:INSY)
Historical Stock Chart
From Mar 2024 to Apr 2024
INSYS THERAPEUTICS, INC. (NASDAQ:INSY)
Historical Stock Chart
From Apr 2023 to Apr 2024