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

*Data on File