INSYS Therapeutics Confirms Outcome of FDA Advisory Committee Meeting on Buprenorphine Sublingual Spray
May 22 2018 - 2:08PM
INSYS Therapeutics, Inc. (NASDAQ:INSY), a leader in the
development, manufacture and commercialization of pharmaceutical
cannabinoids and spray technology, confirmed today that an expert
panel convened by the U.S. Food and Drug Administration (FDA) voted
not to recommend approval of the company’s New Drug Application
(NDA) for a buprenorphine sublingual spray as a treatment for
moderate-to-severe acute pain.
“We appreciate the panelists’ perspective and guidance,” said
Steve Sherman, senior vice president of regulatory affairs for
INSYS Therapeutics. “Believing that our sublingual delivery
technology could contribute significantly to bring value to
patients, we will continue to work with the FDA in the coming
months to discuss the path forward for our buprenorphine product
candidate and to build on the current body of evidence for its
efficacy and safety.”
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 addiction to opioids, opioid overdose,
epilepsy, 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: |
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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