February 19, 2019 08:00 AM Eastern Standard Time
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.
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.