INSYS Therapeutics Announces Participation at FDA Advisory Committee Meeting Addressing the Co-Prescribing of Naloxone
December 18 2018 - 6:00AM
INSYS Therapeutics, Inc. (NASDAQ: INSY), a leader in the
development, manufacture and commercialization of pharmaceutical
cannabinoids and spray technology, today announced that Dr. Dean
Mariano, senior director, clinical development and medical affairs
at INSYS, presented during the first day of the U.S. Food and Drug
Administration’s (FDA) Joint Meeting of the Anesthetic and
Analgesic Drug Products Advisory Committee and the Drug Safety and
Risk Management Advisory Committee meeting being held Dec. 17 and
18, 2018.
In his presentation, Dr. Mariano discussed the
importance of co-prescribing naloxone to chronic use opioid
patients; a position supported by data from a recent study
conducted in which co-prescriptions resulted in fewer overdoses and
fewer hospitalizations. Dr. Mariano’s remarks noted that
co-prescribing naloxone may have a positive impact on unintentional
opioid overdose deaths. However, it is difficult to predict who on
chronic opioid therapy will experience an overdose. Therefore, if
naloxone is co-prescribed in a Universal Precautions manner for all
patients receiving chronic opioid therapy, it may have a
significant impact on unintentional opioid overdose deaths.
“Given the ongoing opioid crisis in the United
States, the FDA Advisory Committee meeting on the necessity of
co-prescribing naloxone and opioids is an important step in
understanding how to curb accidental overdoses in chronic use
patients,” said Dr. Ahmed Elkashef, vice president of clinical
development at INSYS Therapeutics. “We were privileged to
participate in this critical discussion and look forward to
providing additional insights on how to best serve and protect
these patients in the future.”
An archive containing meeting materials,
including slides, a transcript, and webcast replay of the meeting,
which was held at the FDA White Oak Campus in Silver Spring,
Maryland, can be found on the FDA website.
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 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.
Forward-Looking
Statements This news release contains forward-looking
statements 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: |
Investor
Relations & Corporate Communications |
|
Jackie Marcus or Chris
Hodges |
|
Alpha IR Group |
|
312-445-2870 |
|
INSY@alpha-ir.com |
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