US FDA 認可するs over-the-反対する sale of overdose 逆転 麻薬 Narcan
By Bhanvi Satija
March 29 (Reuters) - The U.S. Food and 麻薬 行政 on Wednesday 認可するd over-the-反対する (OTC) sales of Emergent BioSolutions Inc's Narcan, 許すing for easier availability of the life-saving 医薬 used to 逆転する opioid overdoses.
The formal 決定／判定勝ち（する） makes Narcan the first naloxone-based 麻薬 利用できる without a prescription.
Emergent said it will make Narcan 利用できる on U.S. 蓄える／店 棚上げにするs and online retailers by late summer.
"I think it's a big 勝利，勝つ. The question now remains about the cost," said Noa Krawczyk, assistant professor at the NYU Grossman School of 薬／医学.
The 契約 drugmaker 拒絶する／低下するd to 株 詳細（に述べる）s on the price of its OTC 見解／翻訳／版 of Narcan.
現在／一般に, a 4-milligram, two-dose pack of the nasal spray has a 卸売物価 of about $120, によれば 46Brooklyn, a 麻薬 pricing 非，不，無-利益（をあげる）.
"For people who need it most, it needs to be at a lower price point than what it is 現在／一般に 利用できる," said Maryann Mason, associate professor of 緊急 薬／医学 at Northwestern University.
The 是認 could 許す for 接近 to the 麻薬 in areas that have concentrated overdose problems and few pharmacies, she said.
Naloxone 速く 逆転するs or 封鎖するs the 影響s of opioids, 回復するing normal respiration, 特に when given within minutes of the first 調印するs of an overdose.
The Biden 行政 has been 押し進めるing for 活動／戦闘, as U.S. 麻薬-関係のある overdose deaths より勝るd 100,000 in 2021, によれば 政府 見積（る）s. The OTC 是認 helps 提携させる the 連邦の 政府's 姿勢 with 明言する／公表するs that already 申し込む／申し出 the nasal spray without prescription at pharma cies.
The FDA 是認 followed a 全員一致の 推薦 from its 独立した・無所属 パネル盤 of 助言者s 支援 OTC use of Narcan, while 示唆するing changes to the 麻薬's 一括ing.
株 of Maryland-based Emergent rose as much as 20.2% to $10.70 in 早期に 貿易（する）ing. They were up more than 5% at $9.37 later on Wednesday.
The 是認 puts Emergent ahead in the OTC 製品 race.
While （判断の）基準 分析家 Robert Wasserman, ahead of the FDA green light, 公式文書，認めるd that Narcan sales had been 拒絶する／低下するing, he 追加するd, "I do think there'll be a big 需要・要求する for the 製品 and I don't think it's going to be too price 極度の慎重さを要する 権利 away either."
Emergent 報告（する）／憶測d a 14% 落ちる in 2022 for its nasal naloxone 製品s, compared with a 40% 増加する in 2021. In late 2021, FDA 認可するd the first generic 見解／翻訳／版 of Narcan, sold by Israeli drugmaker Teva 製薬のs.
The company will have to compete on the price once Narcan begins to 直面する 付加 OTC 競争 later this year, said TD Cowen 分析家 Boris Peaker.
非，不，無-利益（をあげる） 害（を与える） 削減 治療力のあるs' 使用／適用 for its OTC naloxone nasal spray is 現在／一般に under FDA review with a 決定／判定勝ち（する） 推定する／予想するd in July 2023.
(報告（する）／憶測ing by Bhanvi Satija and Pratik Jain in Bengaluru; Editing by Shinjini Ganguli and 法案 Berkrot)
