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Neurelis Announces That Intravail® Licensee ARS Pharmaceuticals Intranasal Epinephrine Program Given Fast Track Designation

-- ARS Pharmaceuticals announced that ARS-1, an intranasal epinephrine spray in development to treat severe allergic reactions, was granted Fast Track designation by the U.S. Food and Drug Administration (FDA)

SAN DIEGO, CA – February 20, 2019 – Neurelis, Inc. announced today that its Intravail® licensing partner, ARS Pharmaceuticals, Inc., received Fast Track designation from the FDA for ARS-1, its novel intranasal epinephrine spray. ARS-1 is being investigated as a treatment for patients with severe allergic reactions to food, medications and insect bites that could lead to life-threatening anaphylaxis.

Neurelis President and CEO Craig Chambliss stated, “This latest news provides more validation of Intravail’s crucial role in the development of innovative products targeting areas of high 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.”

Chambliss said the science of Intravail enables the non-invasive delivery of a broad range of protein, peptide and small molecule drugs, providing several advantages:

  • Increased bioavailability – Addressing sub-optimal bioavailability or route-of-administrations
  • Application to wide range of molecules – Small molecules, therapeutic proteins, peptides, non-peptide macromolecules (up to ~ 30KDa)
  • Safety – Odorless, tasteless, non-toxic, non-mutagenic and non-irritating
  • Solubility in water/oils – Compatible with routine liquid formulation and dispensing processes for ease of scale-up and production

Neurelis’ pipeline utilizes Intravail to develop novel formulations of drugs targeting areas of significant unmet medical needs in central nervous system (CNS) diseases. Neurelis is also fortunate to partner Intravail with a number of licensees furthering the development of important drugs in a variety of diseases - continuing to expand its strategic partnerships to benefit patients, caregivers, and healthcare providers.

About Neurelis

Neurelis, Inc. is a privately-held San Diego-based specialty pharmaceutical company organized to license, develop, and commercialize product candidates for epilepsy and the broader central nervous system (CNS) market. Neurelis is leveraging its expertise in the development and commercialization of CNS compounds and strong relationships with leading researchers and clinicians in these markets to advance unique product candidates to address significant unmet medical needs. The Neurelis technology platform includes Intravail®, ProTek® and Hydrogel™, three proprietary non-invasive drug delivery and stabilization technologies applicable to a wide-range of molecules including therapeutic proteins, peptides, non-peptide macromolecules and small molecules. For more information on Neurelis, please visit

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, 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