Home Food Allergies FDA Accepts New Drug Utility for Nasal Epinephrine Spray Therapy for Anaphylaxis

FDA Accepts New Drug Utility for Nasal Epinephrine Spray Therapy for Anaphylaxis

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ARS Prescribed drugs introduced right this moment that the US Meals and Drug Administration (FDA) has accepted a New Drug Utility (NDA) for his or her neffy® nasal epinephrine system for the emergency therapy of anaphylaxis in adults and kids weighing 66 lbs and extra.

Scientific trials confirmed a 2mg dose of epinephrine administered intranasally offered comparable pharmacokinetics as an administration from a conventional auto-injector.

If neffy is accepted, it might turn into the primary non-injected (i.e. needleless) emergency epinephrine system to come back to market. The FDA has assigned a goal motion date anticipated in mid-2023 per the Prescription Drug Consumer Price Act (PDUFA).

Right here follows the corporate’s press launch saying the FDA’s acceptance of the neffy NDA.


SAN DIEGO–(BUSINESS WIRE)–ARS Prescribed drugs, Inc. introduced right this moment that the U.S. Meals and Drug Administration (FDA) has accepted for evaluation ARS’ New Drug Utility (NDA) for neffy for the emergency therapy of allergic reactions (sort I) together with anaphylaxis in adults and kids ≥30 kg (66 lbs). If accepted by the FDA, neffy can be the primary non-injectable therapy accessible to sufferers with allergic reactions (sort I) together with anaphylaxis.

The FDA has assigned a Prescription Drug Consumer Price Act (PDUFA) goal motion date that’s anticipated in mid-2023.

“The FDA acceptance of our NDA for neffy is a significant milestone in our efforts to carry to sufferers the power to ship epinephrine with comparable pharmacokinetics to an intramuscular injection, however in a needle-free and easy to manage nasal spray,” mentioned Richard Lowenthal, President and CEO of ARS Prescribed drugs. “We respect that the FDA acknowledges the potential medical good thing about this novel strategy to treating sufferers with extreme allergy symptoms and stay up for working with the FDA throughout this course of, with the aim of probably altering the therapy paradigm for the thousands and thousands of sufferers with or at-risk for extreme allergic reactions (sort I).”

The NDA submission to the FDA was primarily based on knowledge from 4 main registration research supporting {that a} 2 mg intranasal dose of neffy met all medical endpoints really useful by regulators and that its pharmacokinetics have been throughout the vary of accepted epinephrine injection merchandise. These knowledge included research in adults, with self-administration and caregiver administration, in addition to in youngsters with Sort I allergy symptoms ≥30 kg (66 lbs). As well as, neffy has been well-tolerated thus far with greater than 500 people receiving no less than one dose, and lots of with repeat administration. The vast majority of opposed occasions in medical trials have been delicate in nature with none significant nasal irritation or ache.

About Allergic Reactions (Sort I) together with Anaphylaxis

Sort I extreme allergic reactions are critical and doubtlessly life-threatening occasions that may happen inside minutes of publicity to an allergen and require quick therapy with epinephrine, the one FDA-approved medicine for these reactions. Whereas epinephrine autoinjectors have been proven to be extremely efficient, there are effectively printed limitations that lead to many sufferers and caregivers delaying or not administering therapy in an emergency scenario. These limitations embody concern of the needle, lack of portability, needle-related security considerations, lack of reliability, and complexity of the gadgets. There are roughly 25 to 40 million folks in the US who expertise Sort I extreme allergic reactions. Of these, solely 3.3 million at the moment have an lively epinephrine autoinjector prescription, and of these, solely half constantly carry their prescribed autoinjector. Even when sufferers or caregivers carry an autoinjector, greater than half both delay or don’t administer the system when wanted in an emergency.

About ARS Prescribed drugs, Inc.

ARS Prescribed drugs is devoted to empowering at-risk sufferers and caregivers to raised defend themselves from extreme allergic reactions that might result in anaphylaxis. The corporate is creating neffy® (beforehand known as ARS-1), an intranasal epinephrine product in medical growth for sufferers and their caregivers with Sort I allergic reactions together with meals, medicines and bug bites that might result in life-threatening anaphylaxis. For extra data, go to www.ars-pharma.com.

Contacts

Media:
Caroline Cunningham
Porter Novelli
Caroline.Cunningham@porternovelli.com

Buyers:
Justin Chakma
ARS Prescribed drugs
justinc@ars-pharma.com