ARS Pharmaceuticals
Biopharmaceutical company focused on developing needle-free intranasal therapies for emergency treatment of severe allergic reactions. The company advances intranasal formulation, device-drug combination development, clinical programs, and commercialization and patient-access initiatives for an epinephrine nasal spray intended to provide an alternative to injectable epinephrine.
Industries
Nr. of Employees
medium (51-250)
ARS Pharmaceuticals
Patents
Products
Needle-free intranasal epinephrine spray for emergency treatment of allergic reactions including anaphylaxis
A single-dose intranasal epinephrine spray indicated for emergency treatment of allergic reactions, including anaphylaxis, in patients meeting specified weight/age criteria. Designed to deliver systemic epinephrine exposure comparable to injectable products and evaluated in clinical and PK studies.
neffy
Neffy is a needle-free epinephrine nasal spray used for the emergency treatment of allergic reactions including anaphylaxis in adults and children who weigh 33 lbs or greater.
Needle-free intranasal epinephrine spray for emergency treatment of allergic reactions including anaphylaxis
A single-dose intranasal epinephrine spray indicated for emergency treatment of allergic reactions, including anaphylaxis, in patients meeting specified weight/age criteria. Designed to deliver systemic epinephrine exposure comparable to injectable products and evaluated in clinical and PK studies.
neffy
Neffy is a needle-free epinephrine nasal spray used for the emergency treatment of allergic reactions including anaphylaxis in adults and children who weigh 33 lbs or greater.
Services
Programs to assist eligible patients with co-pay support and access to prescription therapies.
Programs to assist eligible patients with co-pay support and access to prescription therapies.
Expertise Areas
- Intranasal formulation development
- Clinical trial management for emergency therapies
- Regulatory strategy and submissions (FDA/EMA)
- Device-drug combination development
Key Technologies
- Intranasal drug delivery
- Alkylsaccharide absorption enhancers (mucosal enhancers)
- Nasal spray device assemblies
- Pharmacokinetic (PK) studies
News & Updates
Company product page states the intranasal epinephrine spray is an FDA-approved needle-free epinephrine product for emergency treatment of allergic reactions including anaphylaxis.
Press announcement that the FDA accepted a New Drug Application for the company's intranasal epinephrine product (NDA acceptance announced October 21, 2022).
Company statements indicating a validated MAA in the EU and ongoing regulatory review (announced in 2022 communications).
Company product page states the intranasal epinephrine spray is an FDA-approved needle-free epinephrine product for emergency treatment of allergic reactions including anaphylaxis.
Press announcement that the FDA accepted a New Drug Application for the company's intranasal epinephrine product (NDA acceptance announced October 21, 2022).
Company statements indicating a validated MAA in the EU and ongoing regulatory review (announced in 2022 communications).