Did FDA approve Neffy?

People with serious allergies now have an easier way to be helped if they begin to experience anaphylaxis. The FDA just approved “Neffy.” It's a nasal spray that has the same medication as an Epi-Pen or an Auvi-Q, but there are no needles.

What does Neffy cost?

Is Neffy available now? Gounder says the drug is meant to be available about eight weeks from the FDA approval. In terms of cost, the fee is about $200 out of pocket . "For people who are on commercial insurance, the cost is going to be limited to about $25," Gounder said.

What is Neffy nasal spray?

The US Food and Drug Administration (FDA) has approved the first adrenaline (epinephrine) nasal spray , known as neffy, for the emergency treatment of allergic reactions, including those that are life threatening, in adults and children who weigh at least 30 kg.

When did Auvelity get FDA approval?

The FDA recently approved AUVELITY, an oral medication, for the treatment of major depressive disorder in adults. August 30, 2022 - On August 19, 2022 , the FDA approved AUVELITY — an oral medication manufactured by Axsome Therapeutics — for the treatment of major depressive disorder (MDD) in adults.

When was Arikayce FDA approved?

Development timeline for Arikayce Date Article Sep 28, 2018 Approval FDA Approves Arikayce (amikacin liposome inhalation suspension) to treat Mycobacterium Avium Complex (MAC) Lung Disease Oct 3, 2018

What happens during anaphylaxis?

Anaphylaxis causes the immune system to release a flood of chemicals that can cause you to go into shock — blood pressure drops suddenly and the airways narrow, blocking breathing .

What is the nasal spray that coats the nose?

NoriZite Nasal Spray coats the nasal cavity and creates a fast, long-lasting barrier against airborne viruses. What types of virus does the nasal spray protect against? NoriZite™ Nasal Spray is a medical device with a unique formulation that targets one of the main sites of infection: the nose.

What is in elonide nasal spray?

After initial priming of the ELONIDE Nasal Spray pump (5 sprays, until a uniform spray is observed), each spray delivers approximately 0.1 ml of mometasone furoate suspension , containing mometasone furoate equivalent to 50 micrograms mometasone furoate.

What does nasal spray do to your nostrils?

The simple explanation of nasal sprays is that they target inflammation in your nasal passages, which reduces swelling and helps clear up stuffiness . Some nasal sprays (steroid nasal sprays and antihistamine sprays) are specifically designed to treat allergy symptoms and can be used for the long term.

When was Tagrisso approved by the FDA?

Development timeline for Tagrisso Date Article Mar 31, 2017 Approval Tagrisso (osimertinib) Receives FDA Full Approval Nov 13, 2015 Approval FDA Approves Tagrisso (osimertinib) for EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer 4 more rows Feb 21, 2024

When is finerenone approved by the FDA?

Development timeline for Kerendia Date Article Jul 9, 2021 Approval FDA Approves Kerendia (finerenone) for the Treatment of Patients with Chronic Kidney Disease Associated with Type 2 Diabetes 2 more rows Jul 13, 2021

When did the FDA approve Trikafta?

Marketed by Vertex Pharmaceuticals, Trikafta was first approved by the FDA in 2019 for CF patients 12 and older with at least one F508del mutation, the most common mutation that causes CF. That approval has since been expanded to cover more CF-related mutations and children 6 and older.

USFDA approval granted for first Nasal Spray for allergic reactions (2024)

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The USFDA approval of Neffy marks a pivotal moment for ARS Pharmaceuticals and allergy sufferers alike.

The Health Master

August 10, 2024

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Last Updated on August 16, 2024 by The Health Master

USFDA approval

In a groundbreaking move that could revolutionize allergy management, the US Food and Drug Administration approval (USFDA approval) has been granted to ARS Pharmaceuticals’ nasal spray as the first-ever needle-free emergency treatment for potentially life-threatening allergic reactions.

This innovative solution, set to be marketed under the brand name Neffy, offers a promising alternative to traditional auto-injectors like the EpiPen.

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Overcoming the Fear of Needles

Anaphylaxis, a severe allergic reaction that can be fatal, often strikes without warning.

While auto-injectors containing epinephrine, a life-saving drug, have been the mainstay of treatment, their use can be daunting, particularly for children.

The fear of needles has been a significant barrier to timely administration of this critical medication, often resulting in delayed or avoided treatment.

Neffy, a single-dose nasal spray, is designed to address this challenge.

By eliminating the need for injections, it aims to increase the likelihood of prompt treatment during an anaphylactic episode.

The USFDA approval of Neffy for adult and pediatric patients weighing at least 30 kilograms (approximately 66 pounds) is a major step forward in improving patient outcomes.

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How Does Neffy Work?

Neffy’s effectiveness was established through rigorous clinical trials involving 175 healthy adults.

These studies demonstrated that the nasal spray delivers epinephrine into the bloodstream at comparable levels to traditional injection methods, effectively countering the effects of anaphylaxis.

It’s important to note that while Neffy represents a significant advancement, it’s not a complete replacement for auto-injectors.

Individuals at risk of anaphylaxis should consult with their healthcare providers to determine the most appropriate treatment plan.

A Long-Awaited USFDA Approval

The USFDA approval of Neffy marks a pivotal moment for ARS Pharmaceuticals and allergy sufferers alike.

USFDA approval granted for first Nasal Spray for allergic reactions (2024)

USFDA approval

Overcoming the Fear of Needles

How Does Neffy Work?

A Long-Awaited USFDA Approval

FAQs

Did FDA approve Neffy? ›

When was Tagrisso approved by the FDA? ›

Date	Article
Mar 31, 2017	Approval Tagrisso (osimertinib) Receives FDA Full Approval
Nov 13, 2015	Approval FDA Approves Tagrisso (osimertinib) for EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer