PharmaTher Aims To Mitigate Ketamine Shortage With New FDA Application
PharmaTher Aims To Mitigate Ketamine Shortage With New FDA Application
Specialty biotech company PharmaTher Holdings (OTCQB:PHRRF) reported it has submitted a priority-original Abbreviated New Drug Application (ANDA) for its proprietary racemic ketamine, KETARX, to the FDA.
專業生物技術公司PharmaTher控股(OTCQB：PHRRF)報告已提交優先級-原始簡明新藥申請(ANDA)向FDA出售其專有外消旋氯胺酮KETARX。
The company expects the agency will perform an expedited review of its ANDA, and anticipates KETARX's approval and commercial launch in the U.S. in the second quarter of 2024. Following that, efforts for international approvals to support ketamine's "growing global demand" will be made, PharmaTher stated.
該公司預計，該機構將執行一項加快審查預計KETARX將於2024年第二季度在美國獲得批准並投入商業運營。PharmaTher表示，之後將努力爭取國際批准，以支持氯胺酮“日益增長的全球需求”。
A developer and vendor of specialty pharmaceuticals with growing adoption and novel delivery methods for better patient outcomes, the company's lead drug candidate KETARX aims to "fill the global unmet medical needs for anesthesia, sedation, pain, mental health and neurological indications." Meanwhile, it is advancing microneedle patch PharmaPatch for the delivery of psychedelics, working jointly with partner companies.
作為一家專業藥物的開發商和銷售商，KETARX公司的主要候選藥物KETARX旨在“滿足全球對麻醉、鎮靜、疼痛、心理健康和神經適應症的未得到滿足的醫療需求”。KETARX是一家專業藥物的開發商和供應商，採用了越來越多的藥物和新穎的給藥方法，以改善患者的結果。與此同時，它正在推進微針貼片醫藥貼片與合作夥伴公司合作，提供迷幻劑。
The company's stated priority is commercializing KETARX in the U.S. under ketamine's FDA-approved label through its recent partnership with specialty generic pharmaceutical company Vitruvias Therapeutics. In the future, it expects to market various dosage forms of KETARX, with the option to increase concentration and ready-to-administer applications.
該公司宣稱的優先事項是通過最近與專業仿製藥公司的合作，在美國以氯胺酮的FDA批准的標籤將KETARX商業化玻璃體治療學。在未來，它預計將銷售KETARX的各種劑型，並可以選擇增加集中度和準備好管理應用程式。
In this sense, CEO Fabio Chianelli called the new ANDA represents a significant milestone that would bring PharmaTher one step closer to becoming "a global leader in ketamine" and a commercially-focused specialty company, "offering drugs that are in short supply with growing adoption for on-label and clinical needs."
從這個意義上說，首席執行官法比奧·奇亞內利新的ANDA代表著一個重要的里程碑，它將使PharmaTher更接近成為“氯胺酮的全球領導者”和一家專注於商業的專業公司，“提供短缺的藥物，越來越多的人採用這些藥物來滿足標籤和臨床需求。”
Chianelli added that ketamine "has been on the FDA's drug shortage list for over five years and its potential for mental health, neurological, and pain disorders continues to gain momentum and validation through published clinical research and real-world use cases."
Chianelli補充說，氯胺酮“已經在FDA的藥物短缺名單上五年多了，它對精神健康、神經和疼痛障礙的潛力繼續獲得動力，並通過已發表的臨床研究和現實世界的使用案例得到驗證。”
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Photo: Benzinga edit with photo by qimono on Pixabay and Doc James on Wikimedia Commons.
圖片：Benzinga在Pixabay上編輯齊蒙諾的照片，在Wikimedia Commons上編輯Doc James的照片。