What is Neffy?

Official answer

by Drugs.com

Neffy is a nasal spray that contains epinephrine which may be given to treat a severe allergic reaction, including anaphylaxis, in adults and children who weigh at least 30kg. It is needle-free and simple to administer. If approved, it will be the first non-injectable treatment available for people with type 1 allergies.

Type 1 allergies include conditions such as anaphylaxis, food and drug allergies, urticaria, angioedema, and atopic diseases, such as asthma, rhinitis, conjunctivitis, and dermatitis.

How does Neffy work?

Neffy works in the same way as epinephrine injections, activating both alpha and beta receptors to constrict blood vessels to maintain blood pressure and heart function, and relax smooth muscles in the airways of the lungs to help relieve shortness of breath and wheezing. Epinephrine may also relax smooth muscles of the stomach and intestine to relieve digestive symptoms.

In a severe allergy, Neffy:

Who makes Neffy?

Neffy is made by ARS Pharmaceuticals.

Is Neffy FDA-approved?

Neffy is not yet FDA-approved. The FDA has reviewed the New Drug Application for Neffy that the company submitted on May 12th, 2023, and on September 20, 2023, they decided that the company needs to conduct another study on the drug before it is approved.

The majority of the Pulmonary-Allergy Drugs Advisory Committee members supported the spray for adults (16:6) and children (17:5), but the FDA does not have to follow the advice of the committee members.

How does Neffy compare to an Epipen?

Neffy is a needle-free nasal spray that is sprayed into the nose whereas Epipen is an injection that is given into a big muscle, such as the thigh.

Neffy contains 2mg of epinephrine per dose whereas an Epipen autoinjector contains 0.3mg per dose and an Epipen Junior auto-Injector, delivers 0.15 mg per dose. Neffy delivers a higher dose than Epipen because it is being given via the nose rather than by injection, so a higher dose is needed for the same effectiveness because an injection delivers medicine to the bloodstream more effectively.

Epipen is available in two autoinjectors:

Neffy will only be available as a single-strength nasal spray, containing 2mg of epinephrine.

Submissions to the FDA from ARS Pharmaceuticals for the approval of Neffy indicate that Neffy has met all the clinical endpoints recommended by regulators and that its pharmacokinetics were within the range of approved epinephrine injection products. Trials of Neffy included more than 600 adults and children ≥30 kg (66 lbs), and compared Neffy to an Epipen or other epinephrine autoinjectors, and included studies that looked at the ease of self-administration. It showed that the results for Neffy were neither substantially higher nor lower than injectable epinephrine, with regards to increasing blood pressure and heart rate (these are markers that indicate a response to treatment). Because there is a lack of data investigating how effective epinephrine injections are at saving lives, it is unclear whether a nasal spray will work as well as injectable epinephrine.

Research from the company has also showed that people are more likely to use a nasal spray 18 minutes earlier than injectable epinephrine, and as many as 35 percent more people would carry one with them.

What are the side effects of Neffy?

Neffy was well tolerated in clinical trials and side effects were mild (slight nasal irritation, stinging, or pain).