20 February 2019 - - The US Food and Drug Administration 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, US-based pharmaceutical company ARS Pharmaceuticals, Inc. said.

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 m 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.

ARS Pharmaceuticals is focused on 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 utilised via the oral, buccal, dermal, and intranasal routes of drug administration.