FDA Acceptance of Libervant™ (diazepam) Buccal Film NDA for treatment of seizure clusters in patients between two and five years of age

FDA接受Libervant™ （地西epa）颊膜NDA用于治疗2至5岁患者的癫痫发作

Prescription Drug User Fee Act (PDUFA) target goal date set for April 28, 2024

处方药用户费法案（PDUFA）目标日期设定为2024年4月28日

WARREN, N.J., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics (Formerly known as MonoSolRx) (NASDAQ: AQST) (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today announced acceptance by the U.S.

沃伦，新泽西州，2023年9月11日（GLOBE NEWSWIRE）-Aquestive Therapeutics（以前称为MonoSolRx）（纳斯达克股票代码：AQST）（“公司”或“Aquestive”），一家制药公司，推出药物以解决患者目前的护理标准问题，并提供变革性的产品来改善他们的生活，今天美国宣布接受。

Food and Drug Administration (FDA) of the Company’s NDA for Libervant™ (diazepam) Buccal Film in pediatric patients between two and five years of age and the assignment of a PDUFA goal date of April 28, 2024..

该公司Libervant NDA的食品和药物管理局（FDA）™ （地西泮）2至5岁儿科患者的口腔薄膜和2024年4月28日PDUFA目标日期的分配。。

Aquestive’s NDA for approval of Libervant™ (diazepam) Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) in patients between two and five years of age has been accepted by the FDA. Diastat® (diazepam) Rectal Gel is the only treatment currently available to this patient population for this indication.

Aquestive的NDA批准Libervant™ （地西epa）颊膜，用于急性治疗2至5岁患者的间歇性，刻板性发作的频繁发作活动（即发作簇，急性重复性发作）。Diastat®（地西泮）直肠凝胶是目前该患者群体唯一可用于该适应症的治疗方法。

The Company received tentative approval for Libervant for the treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) in patients 12 years of age and older in August 2022, but Libervant is currently under an orphan drug block to market access until January 2027..

该公司于2022年8月获得Libervant的初步批准，用于治疗12岁及以上患者的间歇性，刻板性频繁癫痫发作（即癫痫发作集群，急性重复性癫痫发作），但Libervant目前正处于孤儿药市场准入阶段，直至2027年1月。。

“The FDA’s acceptance of our most recent filing for Libervant is another step forward in bringing this important treatment option to patients,” said Daniel Barber, Chief Executive Officer of Aquestive. “When it comes to the treatment of seizure clusters in pediatric patients with epilepsy five years of age and under, physicians and caregivers have limited options.

Aquestive首席执行官丹尼尔·巴伯（Daniel Barber）说：“FDA接受我们最近提交的Libervant申请是向患者提出这一重要治疗方案的又一步。“在治疗5岁及以下癫痫患儿的癫痫发作群时，医生和护理人员的选择有限。

We believe Libervant, as an oral alternative to existing device-based products, will be well-received by this patient population, if approved with market access.”.

我们相信，如果获得市场准入批准，Libervant作为现有基于设备的产品的口服替代品将受到该患者群体的好评。

About Libervant

关于利伯万特

Libervant is a buccally, or inside of the cheek, administered film formulation of diazepam, a benzodiazepine intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern.

Libervant是一种颊部或颊部内部给药的地西泮薄膜制剂，一种苯二氮卓类药物，用于急性治疗与患者通常的癫痫发作模式不同的频繁癫痫发作活动（即癫痫发作，急性重复性癫痫发作）的间歇性，刻板性发作。

Aquestive developed Libervant as an alternative to the device-based products currently available for patients with refractory epilepsy, including a rectal gel and nasal spray products. The FDA has granted tentative approval for Libervant for treatment of these epilepsy patients 12 years of age and older, with U.S.

Aquestive开发了Libervant作为目前可用于难治性癫痫患者的基于设备的产品的替代品，包括直肠凝胶和鼻喷雾剂产品。FDA已批准Libervant与美国一起治疗这些12岁及以上的癫痫患者。

market access for Libervant for this age group of patients subject to the expiration of the existing orphan drug market exclusivity of a previously FDA approved drug scheduled to expire in January 2027. The NDA submitted today for Libervant for epilepsy patients between two and five years of age is subject to FDA approval, including for U.S.

Libervant对这一年龄组患者的市场准入受限于现有的孤儿药市场排他性，该药物将于2027年1月到期。今天提交给Libervant的两岁至五岁癫痫患者的NDA需要FDA批准，包括美国。

market access..

市场准入。。

About Aquestive

关于Aquestive

Aquestive is a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives. We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies.

Aquestive是一家制药公司，致力于推进药物治疗，以解决患者目前的护理标准问题，并提供变革性产品以改善他们的生活。我们正在开发口服给药产品以提供复杂的分子，为侵入性和不便的标准护理疗法提供新的替代方案。

Aquestive has five commercialized products marketed by its licensees in the U.S. and around the world, and is the exclusive manufacturer of these licensed products. The Company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven drug development and commercialization capabilities.

Aquestive在美国和世界各地拥有5家由其许可证持有者销售的商业化产品，并且是这些许可产品的独家制造商。该公司还与制药公司合作，使用专有的一流技术（如PharmFilm®）将新分子推向市场，并已证明药物开发和商业化能力。

Aquestive is advancing a late-stage proprietary product pipeline focused on treating diseases of the central nervous system and an earlier stage pipeline for the treatment of severe allergic reactions, including anaphylaxis. For more information, visit Aquestive.com and follow us on LinkedIn..

Aquestive正在推进专注于治疗中枢神经系统疾病的后期专有产品管道和用于治疗严重过敏反应（包括过敏反应）的早期管道。欲了解更多信息，请访问Aquestive.com并关注LinkedIn。。

Forward-Looking Statement

前瞻性声明

Certain statements in this press release include “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and similar expressions, are intended to identify forward-looking statements.

本新闻稿中的某些陈述包括1995年“私人证券诉讼改革法”含义内的“前瞻性陈述”。诸如“相信”，“预期”，“计划”，“期望”，“估计”，“意图”，“可能”，“将会”或这些术语的否定以及类似的表达方式等词语旨在识别前瞻性陈述。

These forward-looking statements include, but are not limited to, statements regarding the approval and related timing of the NDA for Libervant by the FDA for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy between two and five years of age; regarding the approval for U.S.

这些前瞻性声明包括但不限于关于FDA批准NDA Libervant用于间歇性急性治疗的批准和相关时机的声明，频繁发作活动的定型发作（即发作簇，急性重复性发作），与2至5岁癫痫患者的常规发作方式不同；关于美国的批准。

market access of Libervant for these epilepsy patients aged 12 and older, and overcoming the orphan drug market exclusivity of a competing FDA approved nasal spray product extending to January 2027 for this age group of the patient population; regarding the potential benefits Libervant could bring to patients; and other statements that are not historical facts.

对于这些12岁及以上的癫痫患者，Libervant的市场准入，以及克服FDA批准的竞争性鼻喷雾剂产品的孤儿药市场排他性，该产品延长至2027年1月，适用于该年龄组患者；关于Libervant可能给患者带来的潜在益处；和其他不是历史事实的陈述。

These forward-looking statements are subject to the uncertain impact of the COVID-19 global pandemic on the Company’s business including with respect to its clinical trials, including site initiation, enrollment and timing and adequacy of clinical trials, on supply chain, manufacture, and distribution; and ongoing availability of an appropriate labor force and skilled professionals to produce our products..

这些前瞻性陈述受到COVID-19全球流行病对公司业务的不确定影响，包括其临床试验，包括现场启动，注册和临床试验的时间安排和充分性，供应链，制造，和分销；并持续提供适当的劳动力和熟练的专业人员来生产我们的产品。。

These forward-looking statements are based on the Company’s current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks that the FDA will not approve Libervant for epilepsy patients between two and five years of age or grant U.S.

这些前瞻性声明基于公司当前的预期和信念，并存在许多风险和不确定性，可能导致实际结果与前瞻性声明中描述的结果大不相同。这些风险和不确定性包括但不限于FDA不批准2至5岁癫痫患者的利伯文或授予美国的风险。

market access for Libervant for any age group of the epilepsy patient population, including as covered under the NDA for Libervant submitted for epilepsy patients aged two to five, by overcoming the seven year orphan drug market exclusivity of an FDA approved competing product in effect until January 2027, and there can be no assurance that the Company will be successful in obtaining any such product approval or approval for U.S.

通过克服FDA批准的竞争产品的七年孤儿药物市场独占性，Libervant适用于任何年龄组的癫痫患者人群，包括NDA针对Libervant提交给2至5岁癫痫患者的市场准入，直到2027年1月，并且不能保证公司将成功获得美国的任何此类产品批准或批准。

market access; risk that a competing pediatric epilepsy product of Libervant will receive FDA approval prior to the Company’s receipt of FDA approval of the Libervant NDA for this pediatric age group of the epilepsy patient population; risk relating to the unpredictability of the FDA’s decisions regarding orphan drug exclusivity; risk of litigation brought by third parties relating to overcoming their orphan drug exclusivity of an FDA approved product should the FDA approve Libervant for U.S.

市场准入；Libervant的竞争性小儿癫痫产品在公司收到FDA批准Libervant NDA用于癫痫患者人群的这个儿科年龄组之前将获得FDA批准的风险；与FDA关于孤儿药排他性决定的不可预测性有关的风险；如果FDA批准美国的Libervant，第三方就克服FDA批准的产品的孤儿药专有权而提起诉讼的风险。

market access for any age group of epilepsy patients; risk in obtaining market access for Libervant for other reasons; risks associated with the Company’s development work, including any delays or changes to the timing, cost and success of the Company’s product development activities; risk of the Company’s failure to generate sufficient data in its NDA submission for FDA approval of Libervant, and there can be no assurance that t.

任何年龄组癫痫患者的市场准入；出于其他原因获得Libervant市场准入的风险；与公司开发工作相关的风险，包括公司产品开发活动的时间，成本和成功的任何延迟或变化；公司未能在其NDA提交中生成足够数据以获得FDA批准Libervant的风险，并且无法保证t。

PharmFilm® and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc.

PharmFilm®和Aquestive徽标是Aquestive Therapeutics，Inc。的注册商标。

Investor Inquiries:

投资者查询：

ICR Westwicke

ICR Westwicke

Stephanie Carrington

斯蒂芬妮·卡林顿

stephanie.carrington@westwicke.com

stephanie.carrington@westwicke.com

646-277-1282

646-277-1282