ARS Pharmaceuticals Announces FDA Fast Track Designation for ARS-1 Intranasal Epinephrine Spray

SAN DIEGO, Calif.–(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 that the U.S. Food and Drug Administration (FDA) has granted
Fast Track Designation for ARS-1, an investigational intranasal
epinephrine spray that could 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 FDA’s decision to grant Fast Track Designation for our novel
intranasal epinephrine spray is an important milestone in our mission to
deliver a reliable needle-free treatment option that is easier to carry
and use for the emergency treatment of severe allergic reactions that
could lead to anaphylaxis,” said Richard Lowenthal, President and Chief
Executive Officer of ARS Pharmaceuticals. “Fast Track Designation is an
acknowledgement from the FDA of the potential contribution of our low
dose intranasal epinephrine product for patients and caregivers, and we
look forward to advancing the development of ARS-1 so it is available to
the community as soon as possible.”

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. 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®

Intravail® is a registered trademark of Neurelis, Inc. Intravail® drug
delivery technology 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. Intravail® can be
utilized via the oral, buccal, dermal, and intranasal routes of drug
administration.

Contacts

Sheryl Seapy
W2O pure
213-262-9390
[email protected]

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