First presentation of findings from EPI03, EPI04 and EPI07 studies that examine the pharmacokinetics and pharmacodynamics of single and repeat administration of epinephrine after intranasal, intramuscular and subcutaneous administration
Additional analyses measure the effects of active seasonal allergic rhinitis symptoms on the absorption of intranasal epinephrine administered as Neffy™, and develop learnings for professional and patient education based on U.S. claims data
SAN DIEGO, March 2, 2020 – ARS Pharmaceuticals, Inc., will present new data from three pivotal clinical studies intended to support an NDA for Neffy™ (epinephrine nasal spray) at the American Academy of Allergy, Asthma and Immunology (AAAAI) 2020 annual meeting in Philadelphia, March 13-16, 2020. Data include presentations on Neffy™, an investigational intranasal epinephrine spray that may provide an easy-to-use, needle-free, convenient and more reliable treatment for severe allergic reactions to food, medications and insect bites that could lead to life-threatening anaphylaxis.
Data from Neffy™ studies (EPI03 and EPI04/EPI07 combined) will be presented as oral presentations. Together the two presentations examine the pharmacokinetics and pharmacodynamics of epinephrine after intranasal, intramuscular and subcutaneous administration after single and repeat administration. The effects of active seasonal allergic rhinitis symptoms on the absorption of intranasal epinephrine were also examined. Two additional abstracts will be presented as posters, which include data from EPI04 in allergic rhinitis patients and a study that analyzes data from a U.S. claims database to draw learnings from epinephrine treatment characteristics in patients with severe allergic reactions, including anaphylaxis, to help improve professional and patient education.
“We are excited to be at AAAAI debuting these novel data from three of our key registration studies that demonstrate Neffy™ has the potential to be a safe and effective alternative to auto-injectors for the emergency treatment of life-threatening allergic reactions,” said Richard Lowenthal, President and Chief Executive Officer of ARS Pharmaceuticals. “Neffy™ is a simple to use, rapidly administered and needleless solution for emergency administration of epinephrine in an emergency setting that we believe will make a difference in the lives of patients with severe allergies and their families. We look forward to further engaging with the patient and research communities to ensure it is available to patients as soon as possible.”
Select studies, along with the dates, times and locations of their data sessions, are highlighted below.
Anaphylaxis: A Worldwide Problem (Oral Abstract Session) A Phase 1, Five-Period, Five-Treatment, Randomized Crossover Study of the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Epinephrine After Administration of Intranasal (IN) ARS-1 and Intramuscular (IM) Epinephrine to Healthy Volunteers (Study EPI 03)
- Saturday, March 14, 2:45 pm-3:00 pm
- Full session: 2:00 pm-3:15 pm
Anaphylaxis: A Worldwide Problem (Oral Abstract Session) Comparison of the Pharmacokinetics and Pharmacodynamics of Epinephrine After Intranasal (IN), Intramuscular (IM) and Subcutaneous (SC) Administration in Three Landmark Studies (Studies EPI 03, EPI 04, EPI 07)
- Saturday, March 14, 3:00 pm-3:15 pm
- Full session: 2:00 pm-3:15 pm
Anaphylaxis (Poster Presentation) Determination of the Effects of Active Seasonal Allergic Rhinitis Symptoms (Nasal Edema and Congestion) on the Absorption of Intranasal (IN) Epinephrine Administered as ARS-1 (Study EPI 04)
- Saturday, March 14, 9:45 am-10:45 am
- Convention Center, 200 Level, Hall D
Anaphylaxis (Poster Session) Learning From Epinephrine Treatment Characteristics Among Patients With Severe Allergic Reactions Including Anaphylaxis to Improve Professional and Patient Education: Analyses From a US Claims Database
- Saturday, March 14, 9:45 am-10:45 am
- Convention Center, 200 Level, Hall D
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 investigational 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.
About ARS-1
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 (1.0 mg epinephrine administered). 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.
ARS-1 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) in February 2019. 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.
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 million 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.
About Intravail®
The sprayer is uniquely formulated with Intravail®, an absorption enhancing technology. Intravail® 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.
Contact: Ben Shannon
ben.shannon@porternovelli.com
(919) 360-3039
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