NeffyTM 1 mg
(epinephrine nasal spray)

Small Device. Big Impact.

Neffy™ is a low-dose intranasal epinephrine nasal spray in clinical development for severe allergic reactions that can lead to anaphylaxis.

Anaphylaxis is a severe, life-threatening allergic reaction that can start ordinarily, progress quickly — as fast as within a couple of minutes — and can be fatal if not treated immediately.

Easy-to-use and needle-free, Neffy may eliminate the anxiety and hesitation associated with using an injection device. With use at the first signs of allergic response, Neffy could provide patients and their families the preventive solution to anaphylactic progression.

Investigational New Drug - Not Available For Commercial Distribution

Neffy™ 1 mg (epinephrine nasal spray)

Potential Benefits

Needle-Free
Administration

User-friendly design may enable fast, easy and pain-free epinephrine delivery at the first sign of a severe allergic reaction.

Dependable
Delivery

Developed with Intravail®, an absorption-enhancing technology that enables the reliable and rapid delivery of epinephrine comparable to intra-muscular injection with a low-dose spray into the nose.*

Pocket-Sized
Protection

Small and light enough to carry in a pocket or purse, or on a keychain—anytime, anywhere.

A Life-Threatening Problem

Epinephrine is the first-line therapy for severe allergic reactions, yet more than half of adult patients prescribed autoinjectors don’t use them when needed due to a range of reasons including:
  • fear of needles
  • bulkiness of the device
  • lack of proper training
  • misconception that epinephrine is only used once symptoms are most severe
These barriers prevent many patients and caregivers from carrying their devices regularly, leading to lack of readiness, added anxiety, and preventable tragedy.

A Potentially Life-Changing Advancement

Neffy™ 1 mg (epinephrine nasal spray) is an innovative product in development for the treatment of severe allergic reactions that patients and caregivers may actually use because of its potentially breakthrough features, including:

  • quick, easy, needle-free administration
  • compact size of device
  • Intravail® technology and proprietary formulation which ensures rapid absorption of low-dose epinephrine, with pharmacokinetics/pharmacodynamics comparable to injection*
  • proven device that is currently used in the treatment of migraines, seizures, and opioid overdoses

If approved for commercial use,  Neffy may be able to support patient preparedness to act quickly and confidently during a crisis, helping to treat severe allergic reactions sooner, when it is most important.

Neffy Device Development Milestones

June 2018
ARS Discovery of Formulation Technology
ARS develops the first successful epinephrine nasal spray utilizing a proprietary formulation with Intravail® absorption technology, creating the opportunity for more effective and safer delivery
June 2018
February 2019
FDA Grants Fast Track Designation
Due to its unique industry- and life-changing potential, Neffy™ 1 mg (epinephrine nasal spray), receives Fast Track Designation within two weeks after filing. The FDA’s decision is a significant step forward in bringing Neffy™ to patients more rapidly.
February 2019
June 2019
Promising Data From EPI 04 Clinical Study
Neffy appeared to demonstrate bioequivalent exposure compared to IM injection and is absorbed two times faster (based on tmax and time to 100 pg/mL). Exposure in rhinitis-induced patients with significant congestion and edema appeared to be even faster than when in normal state with pharmacokinetics in a range of exposures that are known to be safe and effective.
June 2019
August 2019
Promising Results From EPI 03 Clinical Study
Neffy demonstrates bioequivalent epinephrine exposure compared to IM injection with both single and repeat dosing and is absorbed two times faster (based on tmax and time to 100 pg/mL), resulting in a significantly improved hemodynamic response (based on mean increase in systolic blood pressure and heart rate).
August 2019
September 2019
Results Favor ARS Product in EpiPen Comparison From EPI 07 Clinical Study
Neffy demonstrates similar pharmacokinetics to EpiPen injection, but with more rapid tmax and a higher proportion of subjects reaching cmax in the first 20 minutes. Noted change in heart rate and systolic blood pressure indicate more rapid and consistent hemodynamic response with Neffy. With repeat dosing, Neffy (two 1 mg doses 10 minutes apart) demonstrated a more proportional increase in plasma levels and pharmacodynamic response than two injections with EpiPen.
September 2019
March 2020
ARS Pharmaceuticals Announces Composition of Matter patent for ARS-1
ARS announced the United States Patent and Trademark Office issued a key patent for ARS-1 (NeffyTM). This new patent, with expiration in 2038, covers compositions of epinephrine and Intravail®, which is a novel absorption enhancer that enables intranasal delivery of epinephrine at low doses.
March 2020
July 2020
ARS Pharmaceuticals Announces a New Patent on ARS-1
ARS announced the United States Patent and Trademark Office issued a second key patent for ARS-1 (NeffyTM). The new patent with expiration in 2038, covers methods related to the use and intranasal administration for a dose range of 0.1 to 2.4 mg epinephrine for the treatment of a type 1 hypersensitivity allergic reaction with any nasal formulation. This dosage is significantly lower than other reported investigational intranasal epinephrine projects in development and thus helps protects against possible accidental overdose risk during a severe allergic reaction. This followed a patent approved the previous year covering the composition of matter of ARS-1.
July 2020
September 2020
ARS Pharmaceuticals and Recordati Announce Exclusive License for the Rights in Europe and additional countries for NeffyTM
ARS announced that it entered into an exclusive licensing agreement with Recordati for marketing rights in the European Union, Iceland, Liechtenstein, Norway, Switzerland, United Kingdom, Russia/CIS, Turkey, Middle East and French-speaking African countries, for ARS-1 (known as NeffyTM in the United States). This agreement will allow ARS to better protect individuals from severe allergic reactions potentially leading to anaphylaxis and continue the important work of gaining regulatory approval in the United States and globally by providing additional capital through licensing milestones and future royalties on sales.  
September 2020
November 2020
ARS Announces Acceptance of Market Authorization Application submission to European Medicines Agency for NeffyTM
ARS announced that the European Medicines Agency (EMA) accepted a Marketing Authorization Application (MAA) submission for review of NeffyTM, an epinephrine nasal spray, for the emergency treatment of severe allergic reactions, including anaphylaxis.
November 2020

*Data on File

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