FDA Grants Fast Track Designation to Epinephrine Nasal Spray

The FDA has granted Fast Track Designation to an investigational intranasal epinephrine spray that could provide treatment for severe allergic reactions...

The FDA has granted Fast Track Designation to an investigational intranasal epinephrine spray that could provide treatment for severe allergic reactions—due to food, medications and insect bite allergies—that could lead to life-threatening anaphylaxis, according to ARS Pharmaceuticals, the company developing the medication.


The needle-free treatment option, ARS-1, is designed to be easy-to-use, convenient and more reliable than other emergency epinephrine treatments for severe allergic reactions, company officials said in a press release. Richard Lowenthal, President and Chief Executive Officer of ARS Pharmaceuticals, said the product’s Fast Track Designation is an important milestone in delivering that option.


“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,” said Lowenthal, in a prepared statement.


ARS-1 is an aqueous formulation of epinephrine nasal spray developed with a nasal absorption enhancing technology. The product has demonstrated comparable pharmacokinetics to an intramuscular injection of epinephrine in clinical studies using a low and safe intranasal dose.


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, according to the company. The intranasal epinephrine spray is also designed to be user-friendly, needle-free and easily portable to carry in a pocket or purse.


Epinephrine auto-injectors produced by Mylan, includng the EpiPen brand, have been subject to shortages since May 2018. A

was made available in January 2019.

generic epinephrine auto-injector by Teva2

According to published literature obtained by ARS, 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. More than 200,000 emergency room visits due to severe reactions from food allergies are reported annually.


This article was originally published onPharmacyTimes.com


  1. ARS Pharmaceuticals Announces FDA Fast Track Designation for ARS-1 Intranasal Epinephrine Spray [news releasel]. San Diego, California; February 19, 2019: Pure Communications. https://www.businesswire.com/news/home/20190219005141/en/ARS-Pharmaceuticals-Announces-FDA-Fast-Track-Designation. Accessed February 20, 2019.
  2. Kokosky G. Newly Approved Generic Version of EpiPen Is Not Cheaper Than Available Option.Pharmacy Times. https://www.pharmacytimes.com/publications/issue/2019/january2019/newly-approved-generic-version-of-epipen-is-not-cheaper-than-available-option. Published January 27, 2019. Accessed February 20, 2019.

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