{"id":57550,"date":"2023-03-17T09:00:27","date_gmt":"2023-03-17T13:00:27","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=57550"},"modified":"2023-03-31T14:02:25","modified_gmt":"2023-03-31T18:02:25","slug":"zavegepant-fda-approval","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/news\/zavegepant-fda-approval\/","title":{"rendered":"FDA approves nasal spray to treat migraine"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">On March 10, the <\/span><a href=\"https:\/\/www.pfizer.com\/news\/press-release\/press-release-detail\/pfizers-zavzprettm-zavegepant-migraine-nasal-spray\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">U.S. Food and Drug Administration approved<\/span><\/a><span style=\"font-weight: 400;\"> Zavzpret, the first <\/span><span style=\"font-weight: 400;\">calcitonin gene-related peptide (CGRP) antagonist nasal spray to treat acute migraine (with or without aura) in adults. This could mean faster\u2014and more effective\u2014treatment for many of the 40 million people in the U.S. who experience migraine. Read on to see what we know about this new medication and when it will be available.<\/span><\/p>\n<p><b>RELATED: <\/b><a href=\"https:\/\/www.singlecare.com\/blog\/migraine-definition\/\"><b>What is a migraine?<\/b><\/a><b> | <\/b><a href=\"https:\/\/www.singlecare.com\/blog\/news\/migraine-statistics\/\"><b>Migraine statistics<\/b><\/a><\/p>\n<h2><span style=\"font-weight: 400;\">What is Zavzpret?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Manufactured by Pfizer, Zavzpret (zavegepant) is <\/span><span style=\"font-weight: 400;\">a fas<\/span><span style=\"font-weight: 400;\">t-acting medication <\/span><a href=\"https:\/\/www.pfizer.com\/news\/press-release\/press-release-detail\/pfizer-announces-lancet-neurology-has-published-phase-3\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">shown in Phase 3 clinical trials to have broad efficacy<\/span><\/a><span style=\"font-weight: 400;\">. The nasal spray was found to be significantly better than a placebo (inactive medicine) at reducing moderate or severe migraine pain to no pain in as little as 15 minutes after administration. Zavzpret also returned people with migraine to normal function in as little as 30 minutes after administration and was effective at providing sustained pain relief, up to 48 hours after use.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Zavzpret is meant to treat a migraine headache once it has started\u2014it is only approved as an acute treatment and should not be used as a preventive medication, says <\/span><a href=\"https:\/\/profiles.mountsinai.org\/huma-sheikh2\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">Huma Sheikh, MD<\/span><\/a><span style=\"font-weight: 400;\">, a spokesperson for the<\/span> <a href=\"https:\/\/americanheadachesociety.org\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">American Headache Society<\/span><\/a><span style=\"font-weight: 400;\"> and an assistant professor of neurology at Mount Sinai School of Medicine in New York<\/span><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Side effects for Zavzpret may include:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Altered taste<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Loss of the sense of taste<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Nasal discomfort<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Nausea or vomiting<\/span><\/li>\n<\/ul>\n<h3><span style=\"font-weight: 400;\">What is different about Zavzpret?<\/span><\/h3>\n<p><span style=\"font-weight: 400;\">The drug class of CGRP receptor antagonists is <\/span><span style=\"font-weight: 400;\">part of a new generation of migraine drugs that target a protein released by specific nerve endings around the head and brain to prevent the inflammatory response that causes migraine pain. Previously, CGRP treatments were only available by injection or as a pill, such as <\/span><span style=\"font-weight: 400;\">Ubrelvy (ubrogepant) and Nurtec ODT (rimegepant)<\/span><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Zavzpret is the first CGRP antagonist to be approved in nasal spray form, which is notable for two main reasons:<\/span><\/p>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>A nasal application of migraine treatment takes effect faster than oral medications. <\/b><span style=\"font-weight: 400;\">When using a nasal spray, the medication enters the bloodstream through the mucous membranes of the nose. A migraine treatment taken by mouth has to be broken down in the digestive system before it enters the bloodstream. Plus, nausea and vomiting caused by a migraine attack can make oral medication less effective.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Other FDA-approved nasal sprays may have more side effects. <\/b><span style=\"font-weight: 400;\">These older medications, such as <\/span><a href=\"https:\/\/www.singlecare.com\/blog\/sumatriptan-side-effects\/\"><span style=\"font-weight: 400;\">Imitrex (sumatriptan)<\/span><\/a><span style=\"font-weight: 400;\"> nasal spray and <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/migranal\/what-is\"><span style=\"font-weight: 400;\">Migranal (dihydroergotamine mesylate)<\/span><\/a><span style=\"font-weight: 400;\">, also work to treat migraine, but come with side effects<\/span><span style=\"font-weight: 400;\"> such as nausea, nasal discomfort, pounding heartbeat, muscle pain, and dizziness or vertigo.<\/span><\/li>\n<\/ol>\n<h2><span style=\"font-weight: 400;\">When will Zavzpret be available?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Pfizer says that Zavzpret is expected to be available this July<\/span><b>. <\/b><span style=\"font-weight: 400;\">Pricing, and subsequent information about insurance coverage, will be available at launch.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">If not treated, a <\/span><span style=\"font-weight: 400;\">migraine episode can last up to 72 hours\u2014and it\u2019s<\/span> <span style=\"font-weight: 400;\">costly. In the U.S. alone, the medical expenses and loss in productivity directly related to migraine<\/span> <a href=\"https:\/\/americanmigrainefoundation.org\/resource-library\/migraine-facts\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">totals $20 million each year<\/span><\/a><span style=\"font-weight: 400;\">. <\/span><span style=\"font-weight: 400;\">For people living with migraine, Zavzpret will be another potential treatment to reduce the impact of this condition on daily life.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On March 10, the U.S. Food and Drug Administration approved Zavzpret, the first calcitonin gene-related peptide (CGRP) antagonist nasal spray to treat acute migraine (with or without aura) in adults. This could mean faster\u2014and more effective\u2014treatment for many of the 40 million people in the U.S. who experience migraine. Read on to see what we [&hellip;]<\/p>\n","protected":false},"author":85,"featured_media":6927,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[4589,4114],"tags":[4141,4316],"coauthors":[20943],"class_list":["post-57550","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-drug-info","category-news","tag-fda-approvals","tag-migraine","wpautop"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Zavegepant FDA approval of nasal spray<\/title>\n<meta name=\"description\" content=\"The zavegepant FDA approval is the first CGRP antagonist available as a nasal spray. 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