Intranasal Epinephrine Spray Granted Fast Track Designation

The Food and Drug Administration (FDA) has granted Fast Track status to ARS-1 (ARS Pharmaceuticals), an investigational intranasal epinephrine spray being developed to treat severe allergic reactions, including anaphylaxis.

ARS-1 uses Intravail, a proprietary nasal absorption enhancing technology; in clinical studies evaluating a low intranasal dose, ARS-1 has demonstrated comparable pharmacokinetics to intramuscular injections of epinephrine. The spray is being developed as a user-friendly, needle-free option for patients; the Company believes this type of formulation could potentially result in easier and more rapid administration of epinephrine in emergency situations.

“We look forward to advancing the development of ARS-1 so it is available to the community as soon as possible,” said Richard Lowenthal, President and CEO of ARS Pharmaceuticals.

In August 2018, the FDA had granted Fast Track designation to another epinephrine nasal spray being developed by INSYS Therapeutics.

For more information visit ARS-Pharma.com.