Opiant wins FDA priority review for opioid overdose therapy

seekingalpha2023-01-20

Specialty pharma company Opiant Pharmaceuticals (NASDAQ:OPNT) announced that the FDA accepted its New Drug Application (NDA) for nasal opioid overdose therapy OPNT003, granting it the agency’s ...

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The FDA has issued May 22, 2023, as the target action date for its decision speeding up the review period from ten months to six months.  A nasal drug comprising the high-affinity opioid antagonist nalmefene, OPNT003 has undergone several pharmacokinetic  and pharmacodynamic studies, the results","collect":0,"end_time":0,"defaultTopTitle":"seekingalpha.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4181":"酒店及度假村房地产投资信托","BK4007":"制药","PK":"Park Hotels & Resorts Inc.","OPNT":"Opiant Pharmaceuticals, Inc."},"translate_title":"Opiant获得FDA对阿片类药物过量治疗的优先审查","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"INVVY":1,"OPNT":1,"PK":1},"content_text":"Specialty pharma company Opiant Pharmaceuticals (NASDAQ:OPNT) announced that the FDA accepted its New Drug Application (NDA) for nasal opioid overdose therapy OPNT003, granting it the agency’s Priority Review designation. The FDA has issued May 22, 2023, as the target action date for its decision speeding up the review period from ten months to six months.  A nasal drug comprising the high-affinity opioid antagonist nalmefene, OPNT003 has undergone several pharmacokinetic (PK) and pharmacodynamic studies, the results of which have backed the company’s NDA. “The 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,” said Opiant’s (OPNT) Chief Executive Roger Crystal.  Read: Seeking Alpha contributor Bram de Haas comments on the decision by small-cap pharma Indivior PLC (OTCPK:INVVY) to acquire Opiant (OPNT) for nearly $145M in cash.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.3","shortVersion":"4.29.3","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2304793178"}