{"id":2039407,"date":"2023-09-20T20:07:01","date_gmt":"2023-09-21T00:07:01","guid":{"rendered":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/fda-declines-to-approve-nasal-spray-for-severe-allergic-reactions\/"},"modified":"2023-09-20T20:11:52","modified_gmt":"2023-09-21T00:11:52","slug":"fda-declines-to-approve-nasal-spray-for-severe-allergic-reactions","status":"publish","type":"post","link":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/fda-declines-to-approve-nasal-spray-for-severe-allergic-reactions\/","title":{"rendered":"FDA rejects nasal spray for severe allergies."},"content":{"rendered":"<aside class=\"mashsb-container mashsb-main mashsb-stretched\"><div class=\"mashsb-box\"><div class=\"mashsb-count mash-medium\" style=\"float:left\"><div class=\"counts mashsbcount\">14<\/div><span class=\"mashsb-sharetext\">SHARES<\/span><\/div><div class=\"mashsb-buttons\"><a class=\"mashicon-facebook mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/www.facebook.com\/sharer.php?u=https%3A%2F%2Fwww.conservativenewsdaily.net%2Fbreaking-news%2Ffda-declines-to-approve-nasal-spray-for-severe-allergic-reactions%2F\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Facebook<\/span><\/a><a class=\"mashicon-twitter mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/twitter.com\/intent\/tweet?text=&amp;url=https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=2039407&amp;via=ConservNewsDly\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Twitter<\/span><\/a><a class=\"mashicon-subscribe mash-medium mash-nomargin mashsb-noshadow\" href=\"#\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Subscribe<\/span><\/a><div class=\"onoffswitch2 mash-medium mashsb-noshadow\" style=\"display:none\"><\/div><\/div>\n            <\/div>\n                <div style=\"clear:both\"><\/div><\/aside>\n            <!-- Share buttons by mashshare.net - Version: 4.0.47--><blockquote>\n<h2>FDA Declines\u2063 Approval for Nasal Spray Alternative to \u200dInjections for Severe Allergic Reactions<\/h2>\n<p>Federal health regulators have declined to approve a\u200d nasal\u2063 spray called Neffy that was developed as an alternative to injections for treatment of severe allergic reactions, prompting an appeal by the product&#8217;s manufacturer and an outcry by an advocacy group for people with life-threatening allergies.<\/p>\n<\/blockquote>\n<p>The Food and Drug Administration (FDA) <a href=\"https:\/\/www.globenewswire.com\/news-release\/2023\/09\/20\/2746095\/0\/en\/FDA-Issues-Complete-Response-Letter-for-neffy-epinephrine-nasal-spray-New-Drug-Application-with-Request-for-Additional-Study.html\" target=\"_blank\" rel=\"noopener\">has notified<\/a> San Diego-based ARS Pharmaceuticals Inc. \u200bthat they must undertake an \u200badditional study \u200ccomparing the effectiveness of their nasal spray device for epinephrine\u2014a \u200cmedication used to halt potentially life-threatening reactions known as anaphylaxis\u2014to traditional\u200d injections.<\/p>\n<p>The company&#8217;s CEO expressed surprise at the decision and vowed to appeal, while a non-profit\u2062 engaged in food\u200b allergy advocacy\u200d said it was &#8220;frustrated&#8221; by the decision, which forces patients to wait longer\u200c for a needle-free epinephrine delivery device.<\/p>\n<blockquote>\n<h2>&#8216;We Are Very Surprised&#8217;<\/h2>\n<p>The FDA&#8217;s notification came by way of a Complete \u200cResponse Letter \u2063(CRL) to the drugmaker&#8217;s new drug\u200c application for the \u2062Neffy epinepherine nasal spray, \u2062with \u200bthe federal regulator demanding additional testing.<\/p>\n<\/blockquote>\n<div class=\"shortcode\">\n<div class=\"border-comp-divider mb-4 mr-4 w-full max-w-[500px] border px-5 py-4 text-[16px] leading-[20px] text-[#262626] md:float-left\" id=\"in_article_related_stories\">\n<h2 class=\"mb-3 font-sans text-[16px] font-semibold uppercase leading-[19px] text-[#2F2F2F]\">Related Stories<\/h2>\n<div class=\"mb-4 flex gap-2\">\n<div class=\"grow\">\n<div class=\"mb-1 line-clamp-2\"><a href=\"http:\/\/www.theepochtimes.com\/us\/fda-refuses-to-change-anti-ivermectin-statements-after-court-ruling-5492215?ea_src=author_manual&#038;ea_med=related_stories\"><\/p>\n<h3>FDA Refuses \u2064to Change Anti-Ivermectin Statements After Court Ruling<\/h3>\n<p><\/a><\/div>\n<div class=\"text-comp-caption text-[14px] leading-[18px]\">9\/16\/2023<\/div>\n<\/div>\n<div class=\"shrink-0 basis-[120px]\"><a href=\"http:\/\/www.theepochtimes.com\/us\/fda-refuses-to-change-anti-ivermectin-statements-after-court-ruling-5492215?ea_src=author_manual&#038;ea_med=related_stories\"><\/a><\/div>\n<\/div>\n<div class=\"mb-4 flex gap-2\">\n<div class=\"grow\">\n<div class=\"mb-1 line-clamp-2\"><a href=\"http:\/\/www.theepochtimes.com\/article\/fda-has-gone-rogue-by-approving-covid-19-boosters-without-clinical-trials-dr-robert-malone-5490314?ea_src=author_manual&#038;ea_med=related_stories\"><\/p>\n<h3>FDA Has &#8216;Gone Rogue&#8217; in Its Approval of New COVID-19 Boosters: \u2062Dr. Robert\u2062 Malone<\/h3>\n<p><\/a><\/div>\n<div class=\"text-comp-caption text-[14px] leading-[18px]\">9\/13\/2023<\/div>\n<\/div>\n<div class=\"shrink-0 basis-[120px]\"><a href=\"http:\/\/www.theepochtimes.com\/article\/fda-has-gone-rogue-by-approving-covid-19-boosters-without-clinical-trials-dr-robert-malone-5490314?ea_src=author_manual&#038;ea_med=related_stories\"><\/a><\/div>\n<\/div>\n<\/div>\n<\/div>\n<p>ARS&#8217; application for approval was based \u2062on clinical trials in healthy patients and those experiencing mild symptoms from a rhinitis attack, with the spray showing a comparable response to injectable medicines.<\/p>\n<p>The company did\u2062 not, however, test the product on people suffering from anaphylaxis, which is a severe, <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/vegan-mac-and-cheese-recalled-for-containing-milk-without-notice\/\" title=\"Vegan Mac And Cheese Recalled For Containing Milk Without Notice\">life-threatening allergic reaction<\/a>, due to ethical and safety concerns.<\/p>\n<p>ARS said it was caught off guard by the FDA&#8217;s request because an advisory panel\u200c for the\u2064 agency recommended \u2063in May that the nasal spray be approved without the \u200bneed for additional studies demonstrating its efficacy or safety.<\/p>\n<div class=\"shortcode post-related-videos\">\n<div class=\"lazyload-wrapper\">\n<div class=\"lazyload-placeholder\"><\/div>\n<\/div>\n<\/div>\n<p>\u201cWe are very surprised by this action and the late requirement at this time to change the repeat-dose study from a post-marketing requirement,&#8221;\u200c Richard Lowenthal, the company\u2019s chief \u2063executive, said in a statement.<\/p>\n<p>Mr. Lowenthal added that the FDA and ARS were previously aligned that the additional study could be carried out as a post-marketing commitment, meaning after the product\u2062 was approved for sale to the public.<\/p>\n<blockquote>\n<h2>Advisory Panel \u200dGave Neffy Green Light<\/h2>\n<p>The nasal spray passed muster at a \u200d <a href=\"https:\/\/www.theepochtimes.com\/health\/fda-committee-recommends-epinephrine-nasal-spray-for-severe-allergic-reactions-5260479\" target=\"_blank\" rel=\"noopener\">recent \u200cmeeting<\/a> of the FDA\u2019s Pulmonary-Allergy Drugs advisory \u200ccommittee (PADAC), though some members \u200braised concerns that clinical trials were conducted \u200con healthy people or those with mild \u200csymptoms rather\u200c than individuals suffering from severe allergic reactions.<\/p>\n<\/blockquote>\n<p>After weighing data from clinical trials of Neffy on over 600 individuals, the 22-member advisory panel ultimately voted 16\u20132 to recommend approval.<\/p>\n<p>But \u2064the FDA&#8217;s <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/fda-advisory-committee-looks-into-risk-of-heart-inflammation-from-modernas-covid-19-vaccine\/\" title=\"FDA Advisory Committee Looks Into Risk of Heart Inflammation From Moderna\u2019s COVID-19 Vaccine\">advisory committee votes<\/a> aren&#8217;t an automatic blueprint for approval, a fact borne out by the agency&#8217;s request to ARS for more pre-marketing \u200dtests before getting a green\u200d light.<\/p>\n<p>The FDA&#8217;s letter requests the completion of a study assessing repeat doses \u200dof neffy compared to repeat doses of an epinephrine injection product under allergen-induced allergic rhinitis conditions.<\/p>\n<p>These refer to nasal inflammation and symptoms triggered by\u200d exposure to allergens, such as dust mites, pollen, or pet dander.<\/p>\n<p>Mr. Lowenthal said the company plans to appeal the FDA&#8217;s latest decision and resubmit a new application in \u2063the\u200d first \u200chalf of 2024.<\/p>\n<p>Advocates for people with allergies expressed frustration\u200b with \u2064the FDA&#8217;s move.<\/p>\n<div class=\"my-5\">\n<p>\u201cOur community believe this innovation would finally come to the more than\u200d 10% of Americans with\u200b life-threatening food allergies,\u200b but instead, the FDA will force us to wait even longer,\u201d Sung Poblete, chief executive of Food Allergy Research &#038; Education, a nonprofit advocacy group, <a href=\"https:\/\/www.foodallergy.org\/media-room\/statement-sung-poblete-rn-phd-ceo-fare-regarding-frustration-felt-food-allergy-community\" target=\"_blank\" rel=\"noopener\">said in\u2062 a\u2064 statement<\/a>.<\/p>\n<\/div>\n<p>Asked for\u200c comment, an FDA spokesperson told The Epoch Times in an \u2063emailed statement that it cannot disclose\u2064 the\u200c details of existing or potential applications.<\/p>\n<p>However, the\u200c spokesperson added that, as a general \u2062matter,\u200c the FDA sends such letters to\u2064 applications like ARS if\u200d the agency decides not to approve a new drug\u200c for a number of reasons including\u200c &#8220;deficiency in product quality, insufficient\u200d information to determine the product \u200dis safe for use under the conditions in its proposed labeling, or lack of substantial evidence that the drug \u2062product will have the effect it purports to have under the conditions in its proposed labeling.&#8221;<\/p>\n<p>&#8220;The FDA remains\u2063 committed to\u2063 the integrity \u2063of our drug approval process. Drugs must undergo a rigorous evaluation of safety, quality, and effectiveness\u200b before they can be approved,&#8221;\u200d the spokesperson added.<\/p>\n<p>The ARS product is one of\u200d several needle-free devices that are\u2062 under development for the treatment of dangerous reactions to food, insect stings, and\u2063 medications.<\/p>\n<p>A needle-free device like\u200b Neffy could alter treatment for what\u200d the Food Allergy Research &#038; Education organization estimates\u200b is roughly 33 million Americans with life-threatening allergies to food and other triggers.<\/p>\n<p>The group said many such \u2064people eagerly await an alternative to injectables.<\/p>\n<p>&#8220;For 36 \u2063years, the food allergy community\u2019s only treatment\u200b option has been to forcefully insert a needle from an epinephrine auto-injector into the thigh of \u2063the patient,&#8221; Ms. Poblete said.<\/p>\n<p> <\/p>\n<h2> How does the delay in approving the Neffy\u200c nasal spray prolong the access to a much<a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/fda-declines-to-approve-nasal-spray-for-severe-allergic-reactions\/\" title=\"FDA rejects nasal spray for severe allergies.\">-needed needle-free epinephrine delivery device<\/a> for\u200b individuals with\u2064 severe allergic reactions?<\/h2>\n<p><span>  Rescue of patients with severe allergic reactions,\u201d said Lisa Gable, CEO of the\u200c non-profit advocacy group FARE (Food Allergy Research &#038; Education). \u201cThe FDA\u2019s \u2063decision to request \u2064additional studies is\u200c disappointing and prolongs the \u2063access \u2063to a \u200bmuch-needed needle-free\u200c epinephrine delivery \u2063device.\u201d<\/p>\n<p>The \u200cNeffy nasal spray \u2062was developed as a more convenient and less \u2062intimidating alternative to traditional injections for the treatment of severe allergic reactions,\u2064 such as those caused by food allergies, insect stings, or medications. Anaphylaxis, the\u200c most severe\u200d form \u200dof \u2062allergic\u2062 reaction, can result in\u200c difficulty breathing, loss of consciousness, and even death if\u200c not treated immediately. Epinephrine \u2063is the \u2064recommended medication for the emergency \u2064treatment of\u2063 anaphylaxis, and the Neffy nasal spray aimed to \u200bprovide a way for individuals\u2064 to administer epinephrine \u200dquickly \u200dand easily, without the need for a needle.<\/p>\n<p>In \u200btheir \u200bnotification<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Federal health regulators have rejected Neffy, a nasal spray designed as an injection alternative for severe allergies. The manufacturer has appealed, while an advocacy group for those with life-threatening allergies has expressed concern. San Diego&#8217;s ARS has been notified by the FDA of their decision.<\/p>\n","protected":false},"author":118,"featured_media":2039408,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_mo_disable_npp":"","fifu_image_url":"https:\/\/cndimages.nyc3.digitaloceanspaces.com\/breaking-news\/wp-content\/uploads\/2021\/01\/IMG_2758-scaled-1.jpg","fifu_image_alt":"","footnotes":""},"categories":[543],"tags":[],"class_list":["post-2039407","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-the-epoch-times"],"fifu_image_url":"https:\/\/cndimages.nyc3.digitaloceanspaces.com\/breaking-news\/wp-content\/uploads\/2021\/01\/IMG_2758-scaled-1.jpg","_links":{"self":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/2039407","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/users\/118"}],"replies":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/comments?post=2039407"}],"version-history":[{"count":0,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/2039407\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media\/2039408"}],"wp:attachment":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media?parent=2039407"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/categories?post=2039407"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/tags?post=2039407"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}