{"id":454584,"date":"2021-03-10T07:33:37","date_gmt":"2021-03-10T12:33:37","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=454584"},"modified":"2021-03-10T07:33:37","modified_gmt":"2021-03-10T12:33:37","slug":"biohavens-nurtec-odt-approved-in-israel-for-acute-treatment-of-migraine","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/biohavens-nurtec-odt-approved-in-israel-for-acute-treatment-of-migraine\/","title":{"rendered":"Biohaven’s NURTEC\u00ae ODT Approved In Israel For Acute Treatment Of Migraine"},"content":{"rendered":"
\n

– NURTEC ODT is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting orally disintegrating tablet (ODT)<\/h2>\n

– A single oral dose of NURTEC ODT 75 mg can provide fast pain relief and return patients to normal function within 60 minutes, and deliver sustained efficacy that lasts up to 2 days for many patients<\/h2>\n

– 86 percent of patients treated with a single dose of NURTEC ODT did not use a migraine rescue medication within 24 hours<\/h2>\n

PR Newswire<\/p>\n<\/p><\/div>\n

\n

\n NEW HAVEN, Conn.<\/span>, March 10, 2021<\/span> \/PRNewswire\/ —\u00a0Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) (“Biohaven”) and Medison Pharma announced today that NURTEC\u00ae ODT (rimegepant) was approved by the Israeli Ministry of Health\u00a0for the acute treatment of migraine with and without aura<\/span> in adults. NURTEC\u00a0ODT is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting orally disintegrating tablet (ODT) approved for the acute treatment of migraine.<\/p>\n

\n

\n
\n \"NURTEC\u2122
\n <\/a>\n <\/p>\n<\/p><\/div>\n

\n Vlad Coric<\/span>, M.D., Chief Executive Officer of Biohaven commented, “We are excited about this first regulatory approval of NURTEC ODT outside of the United States.\u00a0Approval of NURTEC ODT in Israel<\/span> is an important step towards our goal of helping patients worldwide suffering from migraine and the strategic partnership with Medison Pharma will allow us to quickly expand access to NURTEC ODT.”<\/p>\n

A single quick-dissolving tablet of NURTEC ODT can provide fast pain relief and return patients to normal function within one hour, and deliver sustained efficacy that lasts up to 2 days after a single dose for many patients. NURTEC ODT disperses almost instantly in a person’s mouth without the need for water, offering people with migraine a convenient, discreet way to take their medication anytime and anywhere they need it. NURTEC ODT is not indicated for the preventive treatment of migraine. Biohaven partnered with Medison Pharma to pursue regulatory approval of the\u00a0NURTEC ODT dossier in Israel.\u00a0 <\/p>\n

Meir Jakobsohn, Founder and CEO, Medison Pharma commented, “The approval of NURTEC ODT in Israel<\/span> is the result of our companies’ shared efforts and joint commitment to providing access to breakthrough therapies that improve the lives of migraine patients.”<\/p>\n

\n About NURTEC ODT
<\/b>NURTEC\u00ae ODT (rimegepant) is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a quick-dissolve ODT formulation that is approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine in adults. The activity of the neuropeptide CGRP is thought to play a causal role in migraine pathophysiology. NURTEC ODT is a CGRP receptor antagonist that works by reversibly blocking CGRP receptors, thereby inhibiting the biologic activity of the CGRP neuropeptide. The recommended dose of NURTEC ODT is 75 mg, taken as needed, up to once daily. For more information about NURTEC ODT, visit\u00a0www.nurtec.com<\/a>.<\/p>\n

The most common adverse reaction was nausea (2% in patients who received NURTEC ODT compared to 0.4% in patients who received placebo). Avoid concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4, strong or moderate inducers of CYP3A or inhibitors of P-gp or BCRP. Avoid another dose of NURTEC ODT within 48 hours when it is administered with moderate inhibitors of CYP3A4.<\/p>\n

\n Indication
<\/b>NURTEC ODT is indicated for the acute treatment of migraine with or without aura in adults.<\/p>\n

\n Limitations of Use
<\/b>NURTEC ODT is not indicated for the preventive treatment of migraine.<\/p>\n

\n Important Safety Information<\/b>\n <\/p>\n

\n Contraindications: <\/b>Hypersensitivity to NURTEC ODT or any of its components.<\/p>\n

\n Warnings and Precautions:<\/b>\u00a0If a serious hypersensitivity reaction occurs, discontinue NURTEC ODT and initiate appropriate therapy.\u00a0 Serious hypersensitivity reactions have included dyspnea and rash, and can occur days after administration.<\/p>\n

\n Adverse Reactions:<\/b>\u00a0The most common adverse reaction was nausea (2% in patients who received NURTEC ODT compared to 0.4% in patients who received placebo).\u00a0 Hypersensitivity, including dyspnea and rash, occurred in less than 1% of patients treated with NURTEC ODT.<\/p>\n

\n Drug Interactions:<\/b>\u00a0Avoid concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4, strong or moderate inducers of CYP3A or inhibitors of P-gp or BCRP.\u00a0 Avoid another dose of NURTEC ODT within 48 hours when it is administered with moderate inhibitors of CYP3A4.<\/p>\n

\n Use in Specific Populations:<\/b>\n <\/p>\n

    \n
  1. Pregnant\/breast feeding: It is not known if NURTEC ODT can harm an unborn baby or if it passes into breast milk. <\/li>\n
  2. Hepatic impairment: Avoid use of NURTEC ODT in persons with severe hepatic impairment. <\/li>\n
  3. Renal impairment: Avoid use in patients with end-stage renal disease.\u00a0 <\/li>\n<\/ol>\n

    \n Please click here for full<\/b>\u00a0Prescribing Information<\/a><\/u>.<\/p>\n

    \n You are encouraged to report side effects of prescription drugs to the FDA.<\/b>\u00a0Visit www.fda.gov\/medwatch<\/a><\/u>or call 1-800-FDA-1088 or report side effects to Biohaven at 1-833-4Nurtec.<\/p>\n

    Please click here for\u00a0full\u00a0Prescribing Information\u00a0<\/a><\/u>and\u00a0Patient Information<\/a>.<\/u><\/p>\n

    \n About Medison
    <\/b>Medison is one of the world’s largest commercial partners of leading global biotech companies, providing the complete spectrum of integrated services for international companies looking to enter or expand their presence in Israel<\/span>, Canada<\/span> and CEE markets. Medison operates a corporate venture arm with a dedicated research and evaluation team boasting deep scientific and commercial backgrounds. Medison also operates a scouting program to cater its partners and is an active investor in life science projects around drug development and digital health.<\/p>\n

    \n About Biohaven
    <\/b>Biohaven is a commercial-stage biopharmaceutical company with a portfolio of innovative, best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases, including rare disorders. Biohaven’s neuroinnovation portfolio includes FDA-approved NURTEC ODT (rimegepant) for the acute treatment of migraine and a broad pipeline of late-stage product candidates across three distinct mechanistic platforms: CGRP receptor antagonism for the acute and preventive treatment of migraine; glutamate modulation for obsessive-compulsive disorder, Alzheimer’s disease, and spinocerebellar ataxia; and MPO inhibition for multiple system atrophy and amyotrophic lateral sclerosis. More information about Biohaven is available at     www.biohavenpharma.com<\/a>.<\/p>\n

    \n Forward-looking Statement
    <\/b>This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including “believe”, “may” and “will” and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of Biohaven’s management about NURTEC ODT as an acute treatment for patients with migraine. Forward-looking statements include those related to: Biohaven’s ability to effectively commercialize NURTEC ODT, delays or problems in the supply or manufacture of NURTEC ODT, complying with applicable U.S. regulatory requirements, the expected timing, commencement and outcomes of Biohaven’s planned and ongoing clinical trials, the timing of planned interactions and filings with the FDA, the timing and outcome of expected regulatory filings,\u00a0 the potential commercialization of Biohaven’s product candidates, the potential for Biohaven’s product candidates to be first in class or best in class therapies and the effectiveness and safety of Biohaven’s product candidates. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements. Additional important factors to be considered in connection with forward-looking statements are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2021<\/span>. The forward-looking statements are made as of this date and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.<\/p>\n

    NURTEC and NURTEC ODT are registered trademarks of Biohaven Pharmaceutical Ireland DAC.<\/p>\n

    \n Biohaven Contact
    <\/b>Dr. Vlad Coric<\/span>
    Chief Executive Officer
    Vlad.Coric@biohavenpharma.com<\/a><\/p>\n

    \n

    \n
    \n \"NURTEC\u2122
    \n <\/a>\n <\/p>\n

    \n
    \n \"(PRNewsfoto\/Biohaven
    \n <\/a>\n <\/p>\n<\/p><\/div>\n

    \n \"Cision\" View original content to download multimedia:http:\/\/www.prnewswire.com\/news-releases\/biohavens-nurtec-odt-approved-in-israel-for-acute-treatment-of-migraine-301244414.html<\/a><\/p>\n

    SOURCE Biohaven Pharmaceutical Holding Company Ltd.<\/p>\n<\/p><\/div>\n

    \"\"<\/p>\n","protected":false},"excerpt":{"rendered":"

    – NURTEC ODT is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting orally disintegrating tablet (ODT) – A single oral dose of NURTEC ODT 75 mg can provide fast pain relief and return patients to normal function within 60 minutes, and deliver sustained efficacy that lasts up to 2 days for many patients – 86 percent of patients treated with a single dose of NURTEC ODT did not use a migraine rescue medication within 24 hours PR Newswire NEW HAVEN, Conn., March 10, 2021 \/PRNewswire\/ —\u00a0Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) (“Biohaven”) and Medison Pharma announced today that NURTEC\u00ae ODT (rimegepant) was approved by the Israeli Ministry of Health\u00a0for the acute treatment of … <\/p>\n

    Continue reading “Biohaven’s NURTEC\u00ae ODT Approved In Israel For Acute Treatment Of Migraine”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-454584","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nBiohaven's NURTEC\u00ae ODT Approved In Israel For Acute Treatment Of Migraine - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/biohavens-nurtec-odt-approved-in-israel-for-acute-treatment-of-migraine\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Biohaven's NURTEC\u00ae ODT Approved In Israel For Acute Treatment Of Migraine - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"– NURTEC ODT is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting orally disintegrating tablet (ODT) – A single oral dose of NURTEC ODT 75 mg can provide fast pain relief and return patients to normal function within 60 minutes, and deliver sustained efficacy that lasts up to 2 days for many patients – 86 percent of patients treated with a single dose of NURTEC ODT did not use a migraine rescue medication within 24 hours PR Newswire NEW HAVEN, Conn., March 10, 2021 \/PRNewswire\/ —\u00a0Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) (“Biohaven”) and Medison Pharma announced today that NURTEC\u00ae ODT (rimegepant) was approved by the Israeli Ministry of Health\u00a0for the acute treatment of … Continue reading "Biohaven’s NURTEC\u00ae ODT Approved In Israel For Acute Treatment Of Migraine"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/biohavens-nurtec-odt-approved-in-israel-for-acute-treatment-of-migraine\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-03-10T12:33:37+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mma.prnewswire.com\/media\/1453342\/0220_NURTEC_D20028_RT_V4__NEW_FIG_1.jpg\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"6 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/biohavens-nurtec-odt-approved-in-israel-for-acute-treatment-of-migraine\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/biohavens-nurtec-odt-approved-in-israel-for-acute-treatment-of-migraine\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Biohaven’s NURTEC\u00ae ODT Approved In Israel For Acute Treatment Of Migraine\",\"datePublished\":\"2021-03-10T12:33:37+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/biohavens-nurtec-odt-approved-in-israel-for-acute-treatment-of-migraine\\\/\"},\"wordCount\":1269,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/biohavens-nurtec-odt-approved-in-israel-for-acute-treatment-of-migraine\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mma.prnewswire.com\\\/media\\\/1453342\\\/0220_NURTEC_D20028_RT_V4__NEW_FIG_1.jpg\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/biohavens-nurtec-odt-approved-in-israel-for-acute-treatment-of-migraine\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/biohavens-nurtec-odt-approved-in-israel-for-acute-treatment-of-migraine\\\/\",\"name\":\"Biohaven's NURTEC\u00ae ODT Approved In Israel For Acute Treatment Of Migraine - 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(NYSE: BHVN) (“Biohaven”) and Medison Pharma announced today that NURTEC\u00ae ODT (rimegepant) was approved by the Israeli Ministry of Health\u00a0for the acute treatment of … Continue reading \"Biohaven’s NURTEC\u00ae ODT Approved In Israel For Acute Treatment Of Migraine\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/biohavens-nurtec-odt-approved-in-israel-for-acute-treatment-of-migraine\/","og_site_name":"Market Newsdesk","article_published_time":"2021-03-10T12:33:37+00:00","og_image":[{"url":"https:\/\/mma.prnewswire.com\/media\/1453342\/0220_NURTEC_D20028_RT_V4__NEW_FIG_1.jpg","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"6 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/biohavens-nurtec-odt-approved-in-israel-for-acute-treatment-of-migraine\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/biohavens-nurtec-odt-approved-in-israel-for-acute-treatment-of-migraine\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Biohaven’s NURTEC\u00ae ODT Approved In Israel For Acute Treatment Of Migraine","datePublished":"2021-03-10T12:33:37+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/biohavens-nurtec-odt-approved-in-israel-for-acute-treatment-of-migraine\/"},"wordCount":1269,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/biohavens-nurtec-odt-approved-in-israel-for-acute-treatment-of-migraine\/#primaryimage"},"thumbnailUrl":"https:\/\/mma.prnewswire.com\/media\/1453342\/0220_NURTEC_D20028_RT_V4__NEW_FIG_1.jpg","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/biohavens-nurtec-odt-approved-in-israel-for-acute-treatment-of-migraine\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/biohavens-nurtec-odt-approved-in-israel-for-acute-treatment-of-migraine\/","name":"Biohaven's NURTEC\u00ae ODT Approved In Israel For Acute Treatment Of Migraine - 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