ARS制药敦促FDA推迟批准Aquestive的过敏反应治疗药物-动脉网

ARS Pharma Urges FDA To Delay Approval Of Aquestive's Allergic Reaction Treatment

benzinga 等信源发布 2025-09-23 12:01

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ARS Pharmaceuticals Inc.

ARS制药公司

SPRY

敏捷的

filed a petition Monday urging the FDA to delay approval of

周一提交请愿书，敦促 FDA 延迟批准

Aquestive Therapeutics Inc.

Aquestive治疗公司

‘s

AQST

空气质量标准

experimental epinephrine treatment, citing safety, dosing, and

实验性肾上腺素治疗，引用安全性、剂量，和

real-world use concerns

现实世界中的使用问题

。

The filing requests that the FDA withhold approval of AQST-109, a sublingual film branded as Anaphylm. If cleared, ARS wants a boxed warning highlighting potential cardiovascular risks.

该文件请求 FDA 拒绝批准舌下薄膜制剂 AQST-109（品牌名为 Anaphylm）。如果获得批准，ARS 希望加上黑框警告，强调潜在的心血管风险。

ARS argues that current data does not sufficiently demonstrate the drug's safety or efficacy for anaphylaxis patients. The company requested additional studies to address usability and pharmacological concerns.

ARS 认为，目前的数据不足以充分证明该药物对过敏性休克患者的的安全性或有效性。公司要求进行额外的研究以解决可用性和药理学方面的担忧。

Also Read:

另请阅读：

Aquestive Therapeutics Concludes FDA Application For Allergy Drug With Encouraging Pediatric Trial Data

Aquestive Therapeutics凭借鼓舞人心的儿科试验数据完成了过敏药物的FDA申请。

ARS recommended a real-world safety and usability trial with allergy patients. The goal is to assess whether AQST-109 can be reliably absorbed during severe reactions. The firm also called for closer study of the drug's prodrug components and metabolites. It stated that unusual diastolic blood pressure spikes were not seen with other epinephrine formulations..

ARS建议进行一项针对过敏患者的现实世界安全性和可用性试验。目标是评估AQST-109在严重反应期间是否能够可靠吸收。该公司还呼吁对药物的前药成分和代谢物进行更深入的研究。它指出，其他肾上腺素制剂未出现异常的舒张压飙升情况。

The petition urged a pharmacokinetic study of repeated dosing at five-minute intervals to prevent risks from overexposure. ARS warned that approval without such data would be premature and, if cleared, a boxed warning should highlight potential cardiovascular complications.

请愿书敦促进行药代动力学研究，以五分种为间隔的重复给药，来防止过度暴露带来的风险。ARS警告说，没有这些数据就批准还为时过早，如果获得批准，应该用方框警告来强调潜在的心血管并发症。

Citing the FDA's authority under the Food, Drug, and Cosmetic Act to delay approval for safety, ARS noted Aquestive's previous Complete Response Letter for its diazepam buccal film, Libervant, and said AQST-109 poses even greater risks, delivering epinephrine at three times the minimally lethal injection threshold..

援引FDA根据《食品、药品和化妆品法案》在安全性方面延迟批准的权力，ARS提到Aquestive之前为其口腔薄膜药物Libervant（地西泮）收到的完整回应函，并表示AQST-109的风险更大，其提供的肾上腺素剂量是最低致死注射阈值的三倍。

Aquestive submitted its marketing application for AQST-109 on April 1, 2025, with a PDUFA

Aquestive于2025年4月1日提交了AQST-109的上市申请，PDUFA日期待定。

action date of January 31, 2026

2026年1月31日行动日期

。

ARS maintains that, until further research is completed, the application should not move forward.

ARS 坚持认为，在完成进一步研究之前，该申请不应继续进行。

Price Action:

价格行为:

SPRY stock is up 1.89% at $9.98, and AQST stock is up 4.64% at $5.41 at the last check on Tuesday.

SPRY股票上涨1.89%，达到9.98美元，AQST股票上涨4.64%，达到5.41美元，在周二的最后一次检查中。