INSYS Therapeutics Announces Results of PK Study Assessing Proprietary Intranasal Naloxone Formulations versus Intramuscular ...
01 November 2018 - 9:00PM
INSYS Therapeutics, Inc. (NASDAQ: INSY), today announced that a
pharmacokinetic (PK) study (INS012-18-119) of its proprietary
intranasal naloxone spray formulations for the treatment of opioid
overdose showed a distinctive PK profile compared to the current
standards of intramuscular (IM) and intravenous (IV) administration
of naloxone.
According to the U.S. Centers for Disease Control and Prevention
(CDC), there were 70,689 opioid overdoses in the United States in
2017, of which 28,649 or 40 percent were due to synthetic opioids—a
marked increase from 2015, when synthetic opioids accounted for
just 18 percent of total opioid overdoses nationwide. As noted by
Francis S. Collins, MD, PhD, and Nora Volkow, MD, on the NIH
Director’s Blog in May 2017, although naloxone can effectively
reverse opioid overdose, its relatively short half-life compared
with those of synthetic opioids frequently requires multiple doses
to reverse respiratory arrest. The usual doses given of naloxone
may not be powerful or long-lasting enough to reverse overdoses
from highly potent synthetic opioids.
The INSYS study was a single-dose, open-label,
randomized, four-treatment, four-way crossover study. Twenty-four
healthy volunteer subjects received one dose each of 8 mg naloxone
nasal spray (Formulation I and Formulation II), one dose of 2 mg
Naloxone HCl IV Injection (1 mg/mL), and one dose of Naloxone HCl
IM Injection (0.4 mg/mL).
The results from the study, per the graph below,
demonstrate that the mean unconjugated naloxone plasma
concentrations after administration of the two test nasal
formulations:
1) reached appreciably higher levels than those
observed after the administration of the IM dose at all timepoints
beginning at two minutes; and
2) maintained high levels above the Cmax of 0.4
mg IM for two hours.
Unconjugated naloxone exposure generated from
the two test nasal formulations were from 9.6- to 27-fold higher
compared to Naloxone 0.4 mg IM.
The results of this study are consistent with the prior study
conducted by INSYS (INS012-17-108) that compared the company’s two
proprietary nasal formulations with 0.4 mg of Naloxone
Intramuscular
“Due to the introduction of synthetic opioids, a more potent,
longer-lasting naloxone is required to address an unmet need in
today’s opioid epidemic,” said Ahmed Elkashef, M.D., vice president
of clinical development at INSYS. “The PK results from this study
suggest that our naloxone nasal spray formulation may hold promise
to address this unmet need. Based on these results, we look forward
to working with the FDA to bring a new treatment to people on the
front lines of the opioid crisis.”
Upon receiving the results from the nonclinical juvenile
toxicity study, the company plans to file the NDA at the end of the
first quarter of 2019.
About INSYS
INSYS 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.
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 to launch an 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, risks 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 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 |
A graph accompanying this announcement is available at
http://www.globenewswire.com/NewsRoom/AttachmentNg/e3898b15-e29a-4769-ab49-1a42f0748610
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