{"id":724585,"date":"2023-01-19T16:17:58","date_gmt":"2023-01-19T21:17:58","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/opiant-pharmaceuticals-announces-fda-acceptance-and-priority-review-of-nda-for-opnt003-nasal-nalmefene-for-opioid-overdose\/"},"modified":"2023-01-19T16:17:58","modified_gmt":"2023-01-19T21:17:58","slug":"opiant-pharmaceuticals-announces-fda-acceptance-and-priority-review-of-nda-for-opnt003-nasal-nalmefene-for-opioid-overdose","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/opiant-pharmaceuticals-announces-fda-acceptance-and-priority-review-of-nda-for-opnt003-nasal-nalmefene-for-opioid-overdose\/","title":{"rendered":"Opiant Pharmaceuticals Announces FDA Acceptance and Priority Review of NDA for OPNT003, Nasal Nalmefene, for Opioid Overdose"},"content":{"rendered":"<div class=\"mw_release\">\n<ul>\n<li>\n          <em>FDA sets PDUFA date of May 22, 2023<\/em>\n        <\/li>\n<\/ul>\n<p>SANTA MONICA, Calif., Jan.  19, 2023  (GLOBE NEWSWIRE) &#8212; Opiant Pharmaceuticals, Inc.\u00a0(\u201cOpiant\u201d) (NASDAQ: OPNT) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for OPNT003, nasal nalmefene, Opiant\u2019s product candidate for the treatment of opioid overdose.<\/p>\n<p>The NDA was granted a Priority Review designation and has been given a Prescription Drug User Fee Act (PDUFA) action date of\u00a0May 22, 2023, accelerating the review time from ten months to six months from the date of filing.\u00a0Priority Review is granted to therapies that the\u00a0FDA\u00a0determines have the potential to provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious condition.<\/p>\n<p>\u201cWe are delighted to announce that the FDA has accepted Opiant\u2019s NDA for OPNT003 for filing and designated it priority review status,\u201d said Roger Crystal, M.D., President and CEO of Opiant. \u201cThe acceptance of the OPNT003 NDA filing is an important milestone as it brings us one step closer to the potential approval and U.S. commercial launch of OPNT003. We believe the data supporting this NDA indicates that OPNT003 can potentially offer first responders and communities an important treatment option in tackling the very serious opioid overdose crisis. We look forward to working with the FDA during the review process.\u201d<\/p>\n<p>Over 81,000 people in\u00a0the United States\u00a0died of an opioid overdose during the 12 months ended\u00a0August 31, 2022, according to\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=QREsZrlpT95q-S_DD_H9aM3bkAIIqwpGl8zkjS21dQdFuhE9Ydw7PcUzrLWBd78FHmh_hG__9Ww2qEN_Cgq0VsPeDgBIvvnXuGAcxbu6QfWXBf5dkjQPeMrkqrkeL4Pa3szdR-HGHDc3Wn2_4ugTr92ONMJPBRdlaGBr_RSmp5DDuBZrzWcgshrvP1ekrd4HOeCi5x_gKPhx5JHXMhhaS2LzKyYLHJ3K5v1Ib4d9by3SQHpzuFk9Mzf08dkvC31jw0SdIdRVUoyFXPwN0Y1IJPKkPnVD7SeEl-Ah0xqEkbk=\" rel=\"nofollow noopener\" target=\"_blank\">provisional data<\/a>\u00a0from the\u00a0U.S. Centers for Disease Control and Prevention. About 90% \u2013 approximately 73,000 \u2013 of opioid overdose deaths were linked to potent synthetic opioids, driven by illicit fentanyl.\u00a0For each opioid-induced fatality, it has been\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=-1ijs-gKE7OgZaHsPcN3uwovwGj5rGVkyS7hanILPHO9bzH412klvrnCv0t1siJHSfSoIMaiZuFHH7ypCXKE6hH5mmRw8XPd82sweJL5GPYXv6e7GqSgJ46Ot9Wrs_vWdQAxa6bptovt_GQIV-qaKo-BDRVLzKGFDbGHi-hzUBhYWzJAlTvOBPMzsDCl4li5CAA4MEoVWdF0Xv2Eg6za8gnl7PUZBs2UrsHixY7jNjdKMxGPa83qo0Qw245jf_GQ\" rel=\"nofollow noopener\" target=\"_blank\">estimated<\/a>\u00a0there are 6.4-8.4 non-fatal overdoses that can lead to long-term physical and mental disability.<\/p>\n<p>\n        <strong>About OPNT003<\/strong><br \/>\n        <br \/>OPNT003 is a nasal formulation containing the high affinity opioid antagonist nalmefene. The 505(b)2 NDA submission for OPNT003 is supported by results from a pharmacokinetic (PK) study comparing OPNT003 to an intramuscular nalmefene injection (<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=L1bSw7gcUvay-D1L-03IHY3CWBHhIHRrYnWYCB6dg2NVAKz8z-W0fLXV7QTol3A9kvfdLgnRbkodUjOXfvtIijfwF00PE0_aPpXzU8koFGs=\" rel=\"nofollow noopener\" target=\"_blank\">NCT04759768<\/a>), a second PK study comparing a single intranasal dose to a single dose in each nostril or two doses in a single nostril (<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=HBOAg2YNAqtu129KrupA-Nu3FpBPv_rykIKabmuFfA6TkczSeJ7Jzrjbu4otTXGz6PPqNDc87hhjhWOlENBKyH8Ep0xBG-bS36S7LPVyjM95GnkbNa6nd2PN6oWrGQifk9kVcF2HmCdH1M5PSt7UpQ==\" rel=\"nofollow noopener\" target=\"_blank\">NCT05219669<\/a>), and a pharmacodynamic study comparing nasal nalmefene to NARCAN<sup>\u00ae<\/sup> (naloxone HCI) Nasal Spray 4mg in a clinical model of opioid induced respiratory depression (<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=C-GeaivtFebSpFomm9zHXxv7BVT3qaFY4Ls7s7mYh9YXoGXN4OIPvcGityW-qb17mZLub73q6fwXNL9PVwZwgS0ZVsOnmioSy-UawazWSDvo1eKFC8xVkqkI3c4RJP3MWejsTch1Vfao3Ko1n0gyzw==\" rel=\"nofollow noopener\" target=\"_blank\">NCT04828005<\/a>).<\/p>\n<p>An award from the Biomedical Advanced Research and Development Authority (BARDA) for up to $10.8 million, combined with a\u00a0$7.4 million\u00a0grant Opiant received from the\u00a0National Institute on Drug Abuse, have supported the clinical development and U.S. regulatory submission of OPNT003. The contract with BARDA will potentially allow for the development of OPNT003 as a medical countermeasure in a chemical attack using weaponized synthetic opioids as well as a reversal of opioid overdoses in the community.<\/p>\n<p>BARDA is part of the\u00a0Administration for Strategic Preparedness and Response (ASPR) within the\u00a0U.S. Department of Health and Human Services (HHS).\u00a0This project has been funded in whole or in part with federal funds from HHS\/ASPR\/BARDA, under contract number HHSO100201800029C.<\/p>\n<p>\n        <strong>About\u00a0Opiant Pharmaceuticals, Inc.\u00a0<\/strong><br \/>\n        <br \/>Opiant Pharmaceuticals, Inc., is building a leading\u00a0franchise\u00a0of new medicines to combat addictions and drug overdose. For more information visit:\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=WMJ4yVtD0jnpBRVITg44LiXl62P9qzFu8ZgTy05wZz3Tp1lda-pdiBmwHJDeowpbe3uwcrMbRgRT4xq0wixuxeZvOCbYiz2tM3LsWvlG2hsVJOjuyNgg-Oub1SGdP4lG0dz8d87ObVx8ZVzV10410axKXT9huIVtyik2IsGAHwHGM_vLR0yeoGSsm0MOKx3_JdgyCf3mUUSLHUa2OBIVybXwyE1zB8iuADk57R5hhSo=\" rel=\"nofollow noopener\" target=\"_blank\">www.opiant.com<\/a>.<\/p>\n<p>\n        <strong><br \/>\n          <em>Forward-Looking Statements<\/em><br \/>\n        <\/strong><br \/>\n        <br \/>This press release contains forward-looking statements. These statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed, implied or inferred by these forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as \u201cmay,\u201d\u00a0\u201cwill,\u201d\u00a0\u201cshould,\u201d\u00a0\u201ccould,\u201d\u00a0\u201cwould,\u201d\u00a0\u201cexpects,\u201d\u00a0\u201cplans,\u201d\u00a0\u201cintends,\u201d\u00a0\u201canticipates,\u201d\u00a0\u201cbelieves,\u201d\u00a0\u201cestimates,\u201d\u00a0\u201cpredicts,\u201d\u00a0\u201cprojects,\u201d\u00a0\u201cpotential,\u201d\u00a0or \u201ccontinue\u201d\u00a0or the negative of such terms and other comparable terminology. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. Actual events or results may differ materially. In evaluating these statements, you should specifically consider various factors. Additional factors that could materially affect actual results can be found in our Form 10-K for the year ended\u00a0December 31, 2021, and our Form 10-Q for the quarters ended March 31, 2022, June 30, 2022, and September 30, 2022, filed with the\u00a0Securities and Exchange Commission\u00a0on\u00a0March 15, 2022, May 10, 2022, August 11, 2022, and November 14, 2022, respectively, including under the caption titled \u201cRisk Factors.\u201d\u00a0These and other factors may cause our actual results to differ materially from any forward-looking statement. We undertake no obligation to update any of the forward-looking statements after the date of this press release to conform those statements to reflect the occurrence of unanticipated events, except as required by applicable law.<\/p>\n<p>For Media and Investor Inquiries:<br \/>Ben Atkins, Opiant<br \/>(310) 598-5410<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=z41meHs1WrNfkAgzy9gKppiG-H4CI3qQtS7RTzsUWJhO3OST8o8PZfNr8835ZMxchvB7_qNb2lT3YmbPTcDJlMrUDUQAWMrvYrg50SXoZHM=\" rel=\"nofollow noopener\" target=\"_blank\">batkins@opiant.com<\/a><\/p>\n<p>      <img decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODczMzExOCM1MzY0OTAzIzIwMjAwNTY=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" src=\"https:\/\/ml.globenewswire.com\/media\/OTk3ZWIyMDItYWE4NS00NTg0LWFlNTItMGY3OWU4YTNmNDEzLTEwMzE2Mjg=\/tiny\/Opiant-Pharmaceuticals-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>FDA sets PDUFA date of May 22, 2023 SANTA MONICA, Calif., Jan. 19, 2023 (GLOBE NEWSWIRE) &#8212; Opiant Pharmaceuticals, Inc.\u00a0(\u201cOpiant\u201d) (NASDAQ: OPNT) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for OPNT003, nasal nalmefene, Opiant\u2019s product candidate for the treatment of opioid overdose. The NDA was granted a Priority Review designation and has been given a Prescription Drug User Fee Act (PDUFA) action date of\u00a0May 22, 2023, accelerating the review time from ten months to six months from the date of filing.\u00a0Priority Review is granted to therapies that the\u00a0FDA\u00a0determines have the potential to provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/opiant-pharmaceuticals-announces-fda-acceptance-and-priority-review-of-nda-for-opnt003-nasal-nalmefene-for-opioid-overdose\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Opiant Pharmaceuticals Announces FDA Acceptance and Priority Review of NDA for OPNT003, Nasal Nalmefene, for Opioid Overdose&#8221;<\/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-724585","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Opiant Pharmaceuticals Announces FDA Acceptance and Priority Review of NDA for OPNT003, Nasal Nalmefene, for Opioid Overdose - 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\/opiant-pharmaceuticals-announces-fda-acceptance-and-priority-review-of-nda-for-opnt003-nasal-nalmefene-for-opioid-overdose\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Opiant Pharmaceuticals Announces FDA Acceptance and Priority Review of NDA for OPNT003, Nasal Nalmefene, for Opioid Overdose - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"FDA sets PDUFA date of May 22, 2023 SANTA MONICA, Calif., Jan. 19, 2023 (GLOBE NEWSWIRE) &#8212; Opiant Pharmaceuticals, Inc.\u00a0(\u201cOpiant\u201d) (NASDAQ: OPNT) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for OPNT003, nasal nalmefene, Opiant\u2019s product candidate for the treatment of opioid overdose. The NDA was granted a Priority Review designation and has been given a Prescription Drug User Fee Act (PDUFA) action date of\u00a0May 22, 2023, accelerating the review time from ten months to six months from the date of filing.\u00a0Priority Review is granted to therapies that the\u00a0FDA\u00a0determines have the potential to provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of &hellip; Continue reading &quot;Opiant Pharmaceuticals Announces FDA Acceptance and Priority Review of NDA for OPNT003, Nasal Nalmefene, for Opioid Overdose&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/opiant-pharmaceuticals-announces-fda-acceptance-and-priority-review-of-nda-for-opnt003-nasal-nalmefene-for-opioid-overdose\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2023-01-19T21:17:58+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODczMzExOCM1MzY0OTAzIzIwMjAwNTY=\" \/>\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=\"4 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\\\/opiant-pharmaceuticals-announces-fda-acceptance-and-priority-review-of-nda-for-opnt003-nasal-nalmefene-for-opioid-overdose\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/opiant-pharmaceuticals-announces-fda-acceptance-and-priority-review-of-nda-for-opnt003-nasal-nalmefene-for-opioid-overdose\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Opiant Pharmaceuticals Announces FDA Acceptance and Priority Review of NDA for OPNT003, Nasal Nalmefene, for Opioid Overdose\",\"datePublished\":\"2023-01-19T21:17:58+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/opiant-pharmaceuticals-announces-fda-acceptance-and-priority-review-of-nda-for-opnt003-nasal-nalmefene-for-opioid-overdose\\\/\"},\"wordCount\":804,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/opiant-pharmaceuticals-announces-fda-acceptance-and-priority-review-of-nda-for-opnt003-nasal-nalmefene-for-opioid-overdose\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODczMzExOCM1MzY0OTAzIzIwMjAwNTY=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/opiant-pharmaceuticals-announces-fda-acceptance-and-priority-review-of-nda-for-opnt003-nasal-nalmefene-for-opioid-overdose\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/opiant-pharmaceuticals-announces-fda-acceptance-and-priority-review-of-nda-for-opnt003-nasal-nalmefene-for-opioid-overdose\\\/\",\"name\":\"Opiant Pharmaceuticals Announces FDA Acceptance and Priority Review of NDA for OPNT003, Nasal Nalmefene, for Opioid Overdose - 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