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

  • Industry
  • Nation
  • World

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

By

The Health Master

-

206

WhatsAppFacebookTelegramLinkedinTwitterPinterestReddItTumblrEmailPrint

    Table of Contents

    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.

    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.

    Click for more Articles on Pharmaceuticals

    Click for more Legal Articles on Pharmaceuticals

    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.

    The company faced setbacks in the past, with the USFDA initially requesting additional data before granting USFDA approval.

    However, the persistence of ARS Pharmaceuticals and the potential benefits of the product ultimately led to this positive outcome.

    The availability of Neffy is expected to have a profound impact on the lives of countless individuals living with allergies.

    By offering a needle-free alternative to epinephrine administration, this innovative treatment has the potential to save lives and reduce the anxiety associated with severe allergic reactions.

    Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

    Trending

    CDSCO to streamline Drug Regulations for Quality and Patient Safety

    Types of inspections done by USFDA: Read in detail

    USFDA issues Form 483 to Pharma Companies: Let’s know all about it

    USFDA Drug Approval Process: A Comprehensive Guide

    10 Facts about USFDA Approval of Drug

    Understanding GMP, cGMP, and WHO-GMP

    Trending

    USFDA complete audit of Granules Pharmaceuticals with 3 observations

    USFDA approval granted for Trazodone tablets

    USFDA approval granted for Acitretin Capsules USP

    USFDA approval granted for drug against Baldness

    USFDA approval granted for Valsartan Tablets

    USFDA approval granted for Fluphenazine Hydrochloride Tablets USP

    USFDA approval granted for Topiramate Capsules USP

    USFDA approval granted for first Nasal Spray for allergic reactions (2)

    Trending

    USFDA updates norms to conduct Human studies

    Drug recall: Baxter recalls Heparin Sodium Injection Due to this reason

    USFDA approval granted for Trazodone tablets

    CDSCO mandates WHO TRS Guidelines for Sterile Product Manufacturing

    India allows Clinical Trial waivers for Drugs from these 6 Countries

    USFDA approval granted for Acitretin Capsules USP

    New Rules accelerate Drug Approval Process in India

    Gujarat FDCA Launches Crackdown on Fake Drugs: Special Flying Squads Formed

    Govt Job: For Pharmacists in Indian Railways – 246 posts

    USFDA warns of Quality Issues with Chinese Plastic Syringe

    Data integrity is the biggest issue in Pharma Industry: USFDA official

    USFDA approval granted for first Nasal Spray for allergic reactions (3)

    Trending

    FDA: Patients cannot be forced to buy medicines from hospital-attached pharmacies

    Click for Guidance documents for industry

    Click for more Articles on Pharmaceuticals

    Click for more Legal Articles on Pharmaceuticals

    Click here for latest notifications

    For informative videos by The Health Master, click on the below YouTube icon:

    USFDA approval granted for first Nasal Spray for allergic reactions (4)
    • Govt Job: For the post of Director at (RDTL) Regional Drugs Testing Laboratory

    • Phase 3 Clinical Trial for Indigenous Dengue Vaccine Begins in India

    • NPPA revised Ceiling price of 4 scheduled formulation: August 2024

    • Saudi FDA fines 6 Pharma Companies for violating Law

    • USFDA new norms on Container Closure System: A Boon for Indian Pharma?

    For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

    USFDA approval granted for first Nasal Spray for allergic reactions (5)

    For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

    USFDA approval granted for first Nasal Spray for allergic reactions (6)

    For informative videos on consumer awareness, click on the below YouTube icon:

    USFDA approval granted for first Nasal Spray for allergic reactions (7)
    USFDA approval granted for first Nasal Spray for allergic reactions (8)
    USFDA approval granted for first Nasal Spray for allergic reactions (9)
    USFDA approval granted for first Nasal Spray for allergic reactions (10)
    USFDA approval granted for first Nasal Spray for allergic reactions (11)
    USFDA approval granted for first Nasal Spray for allergic reactions (12)
    USFDA approval granted for first Nasal Spray for allergic reactions (13)
    USFDA approval granted for first Nasal Spray for allergic reactions (2024)

    FAQs

    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
    DateArticle
    Sep 28, 2018Approval 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 telithromycin approved by the FDA? ›

    Approval Date: 4/01/2004.

    When was Tagrisso approved by the FDA? ›

    Development timeline for Tagrisso
    DateArticle
    Mar 31, 2017Approval Tagrisso (osimertinib) Receives FDA Full Approval
    Nov 13, 2015Approval 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
    DateArticle
    Jul 9, 2021Approval 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.

    Top Articles
    Latest Posts
    Recommended Articles
    Article information

    Author: Moshe Kshlerin

    Last Updated:

    Views: 6164

    Rating: 4.7 / 5 (77 voted)

    Reviews: 92% of readers found this page helpful

    Author information

    Name: Moshe Kshlerin

    Birthday: 1994-01-25

    Address: Suite 609 315 Lupita Unions, Ronnieburgh, MI 62697

    Phone: +2424755286529

    Job: District Education Designer

    Hobby: Yoga, Gunsmithing, Singing, 3D printing, Nordic skating, Soapmaking, Juggling

    Introduction: My name is Moshe Kshlerin, I am a gleaming, attractive, outstanding, pleasant, delightful, outstanding, famous person who loves writing and wants to share my knowledge and understanding with you.