Results demonstrate rapid epinephrine absorption with an overall
pharmacokinetic profile comparable to epinephrine injection in
allergy-induced patients
SAN DIEGO–(BUSINESS WIRE)–ARS Pharmaceuticals, Inc., a pharmaceutical company dedicated to
empowering at-risk patients and caregivers to better protect themselves
from severe allergic reactions potentially leading to anaphylaxis, today
announced results from its EPI-04 clinical study evaluating the
pharmacokinetics of epinephrine after administration of ARS-1. ARS-1 is
an investigational intranasal epinephrine spray that may provide an
easy-to-use, convenient and more reliable treatment for severe allergic
reactions to food, medications and insect bites that could lead to
life-threatening anaphylaxis. The EPI-04 study is a key step towards
completion of the requirements to file an NDA with the US FDA for ARS-1.
The EPI-04 study was designed to measure the pharmacokinetic (PK)
profile and pharmacodynamic (PD) response to epinephrine after
administration of a 1.0 mg dose of ARS-1 (intranasal epinephrine).
Thirty-six (36) subjects with seasonal allergies received up to five
treatments in a cross-over design to compare the PK/PD response to
epinephrine delivered by ARS-1 or injection. Subjects were randomized to
treatment with 1.0 mg ARS-1 intranasal under non-allergy conditions, 1.0
mg ARS-1 intranasal after induction of rhinitis (severe congestion), a
0.3 mg intramuscular (IM) injection, a 0.5 mg IM injection, or a 0.3 mg
subcutaneous (SC) injection. All injection products were dosed into the
anterolateral thigh area with a needle and syringe – the standard route
of administration for epinephrine injection per the U.S. Food and Drug
Administration (FDA) label.
This study was designed to evaluate the impact of nasal edema and
congestion, which simulate real-world conditions, on the absorption of
epinephrine. The results demonstrate that the exposure (AUC0-t)
and maximum plasma level (Cmax) of a 1.0 mg ARS-1 dose was
comparable to a 0.3 mg IM injection of epinephrine under normal nasal
conditions. The time to maximum plasma level (tmax) and time
to 100 pg/mL of a 1.0 mg ARS-1 dose was faster than IM injection (time
to 100 pg/mL was 9 minutes for ARS-1 and 20 minutes for 0.3 mg IM
injection). The time to 100 pg/mL is considered to be where
pharmacodynamic responses begin to occur.
After induction of rhinitis the epinephrine Cmax upon
administration of 1.0 mg ARS-1 was slightly higher than when subjects
were in a normal condition (i.e. absorption was more rapid). The maximum
plasma exposure observed with ARS-1 when dosed to subjects with moderate
to severe congestion and edema, remained within the range obtained from
doses approved in the US and EU product labeling, thus supporting the
efficacy and safety of ARS-1 under rhinitis conditions.
“In the EPI-04 study, data indicate that nasal delivery of epinephrine
with ARS-1 has a similar pharmacokinetic profile as compared with the
intramuscular injection in subjects with and without
allergic rhinitis but with a faster time to peak exposure,” said Richard
F. Lockey, MD, Professor of Medicine and Pediatrics and the Joy McCann
Culverhouse Chair of Allergy and Immunology at the University of South
Florida. Dr. Lockey is also a consultant on the ARS Medical Advisory
Board. “If approved by the US FDA, results from this study indicate that
the use of ARS-1 may be comparable to epinephrine auto-injectors in
subjects experiencing a systemic allergic reaction or anaphylaxis. The
benefits of this product are that many subjects and caregivers are
apprehensive to dose auto-injectors and a product that is potentially
easier to use, faster to dose, and causes less apprehension, and as such
is an important need in the medical community.”
“The results of the EPI-04 study provide compelling evidence that ARS-1
has the potential to be a safe and effective option for the emergency
treatment of life-threatening allergic reactions that addresses many of
the current obstacles to use of auto-injectors,” said Richard Lowenthal,
President and Chief Executive Officer of ARS Pharmaceuticals. “We
believe these data, along with additional studies discussed with the FDA
that are still ongoing, will be adequate to support approval of ARS-1
for patients over 25-30 kg weight that require emergency treatment of
Type 1 allergic reactions including anaphylaxis. We are also working on
our lower dose product for pediatric patients below 25-30 kg in weight
that we hope to announce soon. If approved, ARS-1 would be the
first-and-only intranasal epinephrine option for patients at risk for
these events, providing a safe, low dose, reliable, needle-free
treatment option that is easier to carry and use. We look forward to
continuing the development of ARS-1 so it is available to the community
as soon as possible.”
About ARS-1
ARS-1 was granted Fast Track Designation by the
U.S. Food and Drug Administration (FDA) in February 2019. Fast track is
a process designed to facilitate the development and expedite the review
of drugs to treat serious conditions and fill an unmet medical need by
providing a therapy where none exist or by providing a therapy which may
be potentially better than available therapy. Its purpose is to get
important new drugs to patients earlier.
ARS-1 is an aqueous formulation of epinephrine nasal spray uniquely
developed with Intravail®, a novel nasal absorption enhancing
technology. ARS-1 has demonstrated comparable pharmacokinetics to an
intramuscular injection of epinephrine in clinical studies using a low
and safe intranasal dose (1.0 mg epinephrine administered). As a result,
the Company believes that the ARS-1 formulation may enable people to
easily deliver epinephrine in emergency situations more rapidly, and
with less hesitation, at the onset of an allergic reaction, as compared
to currently available epinephrine auto-injectors. The intranasal
epinephrine spray is also designed to be user-friendly, needle-free and
easily portable to carry in a pocket or purse anytime, anywhere.
Anaphylaxis is a severe, life-threatening allergic reaction with a
sudden onset that can occur very quickly — as fast as within a couple of
minutes — and could be fatal if not treated immediately. According to
published literature up to 5.3 million people in the United States are
at risk of having an anaphylaxis reaction that may warrant immediate
emergency medical treatment, with more than 200,000 emergency room
visits due to severe reactions from food allergies reported annually.
About ARS Pharmaceuticals, Inc.
ARS Pharmaceuticals is
dedicated to empowering at-risk patients and caregivers to better
protect themselves from severe allergic reactions that could lead to
anaphylaxis. The Company is developing ARS-1, an intranasal epinephrine
spray with a unique absorption technology that could be easy-to-use,
needle-free, convenient and more reliable for patients and loved ones
at-risk of severe allergic reactions to food, medications and insect
bites that could lead to life-threatening anaphylaxis. For more, visit www.ars-pharma.com.
About Intravail®
The sprayer is uniquely formulated with
Intravail®, an absorption enhancing technology. Intravail® enables the
non-invasive delivery of a broad range of protein, peptide and
non-peptide drugs (up to 30,000 daltons in size) that can currently only
be administered by injection.
Contacts
Sheryl Seapy
W2O pure
213-262-9390
sseapy@purecommunications.com