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FDA declines to approve nasal spray alternative to EpiPen

In a surprise to its makers, a nasal spray intended to be an alternative to the EpiPen was sent back by the FDA, the company announced.
FDA denies nasal spray alternative to EpiPen
Posted at 6:10 AM, Sep 20, 2023

Federal regulators called for additional study of Neffy, a nasal spray that could provide an alternative to EpiPens for type 1 allergic reactions, surprising its maker ARS Pharmaceuticals on Wednesday. 

ARS said the Food and Drug Administration requested a "pharmacokinetic/pharmacodynamic study assessing repeat doses of Neffy compared to repeat doses of an epinephrine injection product under allergen-induced allergic rhinitis conditions to support approval."

ARS said Neffy is intended for the immediate and emergency treatment of allergic reactions. The medication could be used following allergic reactions to insect stings, food, drugs and other allergens. 

“With the EpiPens, this is really the only route of epinephrine available for patients to be prescribed in an outpatient setting for use of anaphylactic reactions," said Lauren Frasier, the clinical pharmacy manager at Wesley Medical Center.

"The intranasal route might be able to be used a little more frequently for people that were on the fence about using an EpiPen just because of the way it’s administered," she said. Frasier explained that other intranasal medications have been successful for seizures, drug overdose, and pain, for example.

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In May, the FDA's Pulmonary-Allergy Drugs Advisory Committee voted 16-6 that the results of studies support a favorable benefit-risk assessment for the drug's use for the emergency treatment of allergic reactions for adults. The group also voted 17-5 in favor of the treatment for children. 

“We are very surprised by this action and the late requirement at this time to change the repeat-dose study from a post-marketing requirement, which we had previously aligned on with FDA, to a pre-approval requirement, particularly given the positive Advisory Committee vote. In fact, multiple Committee members highlighted the favorable profile of Neffy in our completed single-dose nasal allergy challenge study and that any decline in exposure 20 minutes after dosing, after the expected response period, is of no concern,” said Richard Lowenthal, CEO of ARS Pharma. “We stand by the totality of the Neffy data package generated in a comprehensive registration program that was aligned upon with FDA and believe strongly in the value Neffy can provide for patients, families and caregivers living daily with severe allergic reactions.”

ARS said it will resubmit its application in the first half of 2024 in hopes of garnering approval in the second half of the year. 

ARS said it is also going through the regulatory process in Europe. It expects an answer from the European Medicines Agency with a Committee for Medicinal Products for Human Use by the end of this year.

According to the Allergy and Asthma Network, 1 in 20 Americans has had anaphylaxis. The group says half of Americans with a food allergy have had a severe allergic reaction. The Allergy and Asthma Network says anaphylaxis causes 225 fatalities a year, and there is no substitute for epinephrine. 

@scrippsnews The first needle-free alternative to the EpiPen is facing setbacks. The Food and Drug Administration has asked ARS Pharmaceuticals to do an additional study on their epinephrine nasal spray product. #allergies #FDA #healthtok ♬ original sound - Scripps News

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