FDA Fast Tracks Intranasal Epinephrine Spray

FEBRUARY 20, 2019
Cecilia Pessoa Gingerich
FDA, The US Food and Drug Administration (FDA) has granted Fast Track Designation to ARS-1, a new intranasal epinephrine spray. The intranasal spray is currently being investigated as a treatment for patients with severe allergic reactions to food, medications, and insect bites that could lead to 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, MS, President and Chief Executive Officer of ARS Pharmaceuticals, in a statement. “Fast Track Designation is an acknowledgement from the FDA of the potential contribution of our low dose intranasal epinephrine product for patients and caregivers.”

Lowenthal added that the company anticipates developing ARS-1 quickly to make the intranasal epinephrine spray available to the community as soon as possible.

The nasal spray is being developed for use with Intravail, a nasal absorption enhancing technology owned by Neurelis, Inc. Use of Intravail technology allows for a needle-free delivery of epinephrine.

Craig Chambliss, President and CEO of Neurelis, said the Fast Track Designation validates the role of Intravail in the development of new products to serve unmet needs.

“We congratulate the ARS team on the tremendous progress of their ARS-1 treatment, which has the potential to offer people at risk for life-threatening anaphylaxis, low-dose, safe, and convenient treatment,” said Chambliss in a press release.

In August 2018, the FDA granted a Fast Track Designation to another epinephrine nasal spray that is being developed by INSYS Therapeutics, Inc.

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