FDA Accepts New Drug Application (NDA) for Buprenorphine Sublingual Spray from INSYS Therapeutics
December 06 2017 - 9:37AM
INSYS Therapeutics, Inc. (NASDAQ:INSY) (“INSYS” or “the company”),
announced today that its New Drug Application (NDA) for a novel
formulation of buprenorphine as a sublingual spray for the
management of moderate-to-severe acute pain has been accepted for
filing by the U.S. Food and Drug Administration (FDA).
Under the Prescription Drug User Fee Act
(PDUFA), the FDA has set a target date of July 28, 2018 to complete
its review of this NDA, which was based primarily on a pivotal
trial that met its primary efficacy endpoint and several
pharmacokinetics studies.
To expand the duration of exposure for this
investigation new drug candidate, INSYS also recently completed a
seven-day safety and tolerability study with 100 patients. Data
from this study will be submitted to the FDA in the first quarter
of 2018, augmenting the NDA package, and may impact the PDUFA
date.
“We look forward to working with the FDA in 2018
to add our buprenorphine sublingual spray to the range of treatment
options available to physicians whose patients suffer from
moderate-to-severe acute pain,” said Steve Sherman, senior vice
president of regulatory affairs at INSYS. “We believe that this
novel formulation and delivery method of buprenorphine holds great
promise as an alternative to traditional opioids.”
INSYS anticipates that the potential benefits of
buprenorphine include a ceiling effect for respiratory depression
and, compared to other opioids frequently used in this indication,
less abuse potential, less cognitive impairment and less
constipation.
“To support the progress of our product pipeline
through the regulatory path, we set a goal this year to file one
NDA per year for the next five years,” said Saeed Motahari,
president and chief executive of INSYS. “With the FDA’s acceptance
of our NDA for buprenorphine sublingual spray, we are off to a good
start.”
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
for anorexia-associated weight loss in cancer and agitation in
Alzheimer’s disease; buprenorphine/naloxone sublingual spray for
opioid dependence; naloxone nasal spray for opioid overdose;
epinephrine nasal spray for anaphylaxis; 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.
Forward-Looking
Statements This news release contains forward-looking
statements including regarding our belief that (i) this novel
formulation and delivery method of buprenorphine holds great
promise as an alternative to traditional opioids and (ii) the
potential benefits of buprenorphine include a ceiling effect for
respiratory depression and, compared to other opioids frequently
used in this indication, less abuse potential, less cognitive
impairment and less constipation. 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