INSYS Therapeutics Announces Results of Dose-Finding PK Study for Epinephrine Nasal Spray for Treatment of Anaphylaxis
09 Gennaio 2019 - 12:00PM
INSYS Therapeutics, Inc. (NASDAQ: INSY), a leader in the
development, manufacture and commercialization of pharmaceutical
cannabinoids and spray technology, today announced the results of a
dose-finding pharmacokinetic (PK) study (INS015-18-124) of its
epinephrine nasal spray. These results identified a dose that
showed a PK profile similar to that of intramuscular injection of
EpiPen® (0.3 mg) and Adrenalin® (0.5 mg), both of which are
treatments for anaphylaxis, an acute, life-threatening allergic
reaction.
The dose-finding PK study, INS015-18-124, was a
single-dose, open-label, randomized, four-treatment, four-way
crossover study to assess the pharmacokinetics of two doses of
epinephrine nasal spray and two reference products, EpiPen® (0.3
mg) and Adrenalin® (0.5 mg) in 49 healthy volunteers.
Additionally, as reported on Jun. 14, 2018, the
proof-of-concept PK study (INS015-17-112), demonstrated rapid drug
absorption through the nasal mucosa and similar bioavailability to
that of an intramuscular injection of EpiPen® (0.3mg) in nasal
allergen challenged subjects.
“The results of our proof-of-concept
(INS015-17-112) and dose-finding (INS015-18-124) studies confirmed
that INSYS’ novel, proprietary formulation of epinephrine delivered
intranasally potentially offers a viable, attractive alternative
and non-invasive delivery option to the currently marketed
products,” said Dr. Venkat Goskonda, senior vice president of
research and development at INSYS Therapeutics. “These results
enable us to select an appropriate dose for advancing to the next
stage of clinical development. We look forward to working with the
FDA to bring a new treatment option for allergy sufferers who
experience anaphylaxis.”
According to the Mayo Clinic, more than 200,000
cases of anaphylaxis occur each year in the United States. The
World Allergy Organization estimates that up to two percent of the
global population — as many as 150 million people worldwide — will
experience anaphylaxis during their lifetime.
The U.S. Food and Drug Administration (FDA)
granted Fast Track designation on Aug. 30, 2018 to the company’s
epinephrine nasal spray as an investigational treatment for
anaphylaxis, an acute, life-threatening allergic reaction requiring
urgent treatment.
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.
Forward-Looking
Statements
This news release contains forward-looking
statements including the potential for Fast Track designation to
expedite the FDA’s review of our epinephrine product candidate and
our belief in this product candidate’s potential to become a
needle-free, non-invasive and easy-to-use alternative to
intramuscular injection for the treatment of anaphylaxis.
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, 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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