SAN DIEGO, March 05, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from

圣地亚哥，2025年3月5日（环球新闻社）-- ARS制药公司（纳斯达克股票代码：SPRY），一家致力于帮助高危患者和护理人员更好地保护自己的生物制药公司，

allergic reactions

过敏反应

that could lead to

可能导致

anaphylaxis

过敏反应

, announced today that the U.S. Food and Drug Administration (FDA) has approved

，今天宣布美国食品药物管理局（FDA）已经批准

neffy

内菲

®

®

1 mg

1毫克

(

(

epinephrine

肾上腺素

nasal spray) for the treatment of Type I Allergic Reactions, including anaphylaxis, in children who are aged 4 years and older and weigh 15 to < 30 kilograms (33 to < 66 lb.). This approval represents the first significant innovation in the delivery of epinephrine for this patient population in more than 35 years..

鼻喷雾剂）用于治疗 4 岁及以上、体重 15 至 <30 公斤（33 至 <66 磅）的儿童的 I 型过敏反应，包括过敏性休克。这一批准代表了 35 年多以来这个患者群体使用肾上腺素方式的首个重大创新。

In the general population, approximately one in 13 children have severe food allergies, and more than 40 percent have experienced severe reactions.

在普通人群中，大约每 13 名儿童中就有 1 名患有严重食物过敏症，其中超过 40% 曾经历过严重反应。

1

1

Despite the clear link between early epinephrine use and better outcomes, research shows that approximately 40 percent of patients delay treatment

尽管早期使用肾上腺素与更好的结果之间存在明显关联，但研究表明大约 40% 的患者延迟治疗。

2

2

, and 56 percent of caregivers fear using needle-based auto-injectors on their child

，56%的护理人员害怕给孩子使用基于针头的自动注射器

3

3

.

。

neffy eliminates needles, delivering a precise epinephrine dose via a simple nasal spray, almost instantly, with no nasal hold time required.

neffy无需针头，通过简单的鼻喷剂几乎瞬间即可输送精确的肾上腺素剂量，且无需鼻腔停留时间。

“Today’s FDA approval of neffy

“今天FDA批准了neffy

1 mg marks a major milestone towards our efforts to transform the management of severe allergic reactions,” says Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharma. “Many children and caregivers fear needle-based auto-injectors, which can delay lifesaving treatment. neffy’s

ARS Pharma公司联合创始人、总裁兼首席执行官理查德·洛温塔尔表示：“1毫克标志着我们在努力改变严重过敏反应管理方面迈出了重要的里程碑。许多儿童和护理人员害怕基于针头的自动注射器，这可能会延误挽救生命的治疗。Neffy的

needle-free, easy-to-use design addresses this unmet need, offering families a long-awaited alternative. With nearly four out of 10 U.S. epinephrine prescriptions written for children under the age of 18—and nearly a third of those for children weighing 15 to 30 kilograms

无针、易于使用的设计满足了这一未被满足的需求，为家庭提供了一个期待已久的替代方案。在美国，近四成的肾上腺素处方是为18岁以下儿童开具的，其中近三分之一是为体重在15至30公斤之间的儿童开具的。

4

4

—we believe neffy

——我们相信neffy

1 mg will improve access to a needle-free option for the treatment of severe allergies and reduce hesitation in treating this vulnerable group. It will also eliminate risks like accidental needle injuries to children or caregivers.”

1毫克将改善严重过敏症治疗中无针头选项的可及性，并减少对这一脆弱群体治疗的犹豫。它还将消除诸如儿童或护理人员意外针刺伤害等风险。

The approval of neffy 1 mg

Neffy 1毫克的批准

is based on data from extensive clinical trials, including pharmacokinetic (PK) and pharmacodynamic (PD) responses in pediatric and adult subjects that were consistent with those of epinephrine injection products. Adverse events in pediatric trials were generally mild and transient. Human factor studies also show children as young as 10 can use neffy.

基于来自广泛临床试验的数据，包括儿科和成人受试者中的药代动力学（PK）和药效动力学（PD）反应，与肾上腺素注射产品一致。儿科试验中的不良事件通常为轻度且短暂。人体因素研究还表明，年仅10岁的儿童也可以使用neffy。

effectively by following instructions, and that even untrained individuals, such as babysitters or teachers, can effectively administer neffy. The device has a shelf-life of 24 months at room temperature and tolerance to temperature exposures up to 122°F (50°C) based on testing for up to 3 months. If accidentally frozen, neffy can be thawed without impact on the product quality and reliability..

通过遵循指示，甚至未经培训的个人，如保姆或教师，也能有效地使用 neffy。该设备在室温下的保质期为 24 个月，并且根据长达 3 个月的测试，能够耐受高达 122°F（50°C）的温度。如果意外冻结，neffy 可以解冻且不会影响产品质量和可靠性。

“The availability of a needle-free epinephrine option for children is a breakthrough in the treatment of severe allergic reactions,” says Dr. David Fleischer, Section Head of Allergy & Immunology, and Professor of Pediatrics, at Children’s Hospital Colorado. “Many people wait to administer epinephrine until symptoms progress or take antihistamines as a first line of defense because they are afraid of injection.

“儿童可用的无针肾上腺素选项是治疗严重过敏反应的一项突破，”科罗拉多儿童医院过敏与免疫科主任、儿科教授大卫·弗莱舍博士说道。“许多人等到症状加重时才使用肾上腺素，或者因为害怕注射而选择抗组胺药作为第一道防线。

neffy’s small, user-friendly design addresses these challenges, empowering people to actually carry epinephrine and act quickly and confidently during an allergic emergency. This innovation will likely significantly improve health outcomes and enhance quality of life.”.

neffy的小巧且用户友好的设计解决了这些挑战，使人们能够真正随身携带肾上腺素，并在过敏紧急情况下迅速且自信地采取行动。这一创新很可能会显著改善健康结果并提升生活质量。

ARS Pharma is committed to access and affordability, and neffy 1 mg is expected to be available in the U.S. by the end of May 2025. The

ARS Pharma致力于可及性和可负担性，预计neffy 1 mg将于2025年5月底前在美国上市。

neffy

内菲

Connect program provides patients, caregivers, and healthcare professionals with information to guide their treatment journey, details about medication fulfillment services, financial support and navigating insurance requirements. Most commercially insured patients will pay no more than $25 for two single-use neffy devices through a co-pay savings program.

Connect计划为患者、护理人员和医疗专业人员提供信息，以指导他们的治疗过程，包括药物配送服务的详细信息、财务支持以及如何处理保险要求。通过共付额节省计划，大多数商业保险的患者购买两个一次性使用的neffy设备时，支付费用不超过25美元。

The co-pay savings card can be accessed at neffy.com and downloaded to an Apple Wallet and provided to the pharmacy. If the product isn’t covered by insurance, the cash price of $199 for two doses is available through BlinkRx and coupon can be downloaded from GoodRx for use at local retail pharmacies.

共付储蓄卡可以在 neffy.com 获取并下载到 Apple Wallet，然后提供给药房。如果产品未被保险覆盖，两剂 199 美元的现金价格可通过 BlinkRx 获得，并且可以从 GoodRx 下载优惠券用于当地零售药店。

For certain uninsured or underinsured U.S. residents meeting eligibility criteria and exhausted all other options, the ARS Pharma Patient Assistance Program (PAP) will provide neffy at no cost..

对于符合资格标准且已用尽其他所有选择的某些未投保或投保不足的美国居民，ARS Pharma 患者援助计划 (PAP) 将免费提供 neffy。

Eligible schools participating in the

符合条件的参与学校

neffy

内菲

inSchools program can receive neffy

学校项目可以接收neffy。

1 mg upon availability. For more information, and to register for

1毫克，视供应情况而定。欲了解更多信息并注册，请

neffy

内菲

Connect, visit

连接，访问

www.neffy.com

www.neffy.com

.

。

The approval of

批准

neffy 1 mg

neffy 1 毫克

follows FDA approval for neffy 2 mg on August 9, 2024 for children and adults weighing 30kg ( 66 lb.), and approval for EUR

紧随2024年8月9日FDA批准neffy 2 mg用于体重30公斤（66磅）及以上的儿童和成人，并获得欧盟批准。

neffy

内菲

in the EU by the European Commission on August 22, 2024.

2024年8月22日，欧盟委员会在欧盟发布。

About neffy®

关于neffy®

neffy is a nasal spray used for emergency treatment of allergic reactions including anaphylaxis, in adults and children aged 4 years and older who weigh 33 lbs. or greater.

neffy 是一种鼻喷雾剂，用于紧急治疗包括过敏性休克在内的过敏反应，适用于4岁及以上且体重33磅或以上的成人和儿童。

INDICATION AND IMPORTANT SAFETY INFORMATION

适应症和重要安全信息

INDICATION

适应症

neffy is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients aged 4 years and older who weigh 33 lbs. or greater.

neffy 适用于治疗 4 岁及以上、体重 33 磅或以上的成人和儿童患者的 I 型过敏反应，包括过敏性休克。

IMPORTANT SAFETY INFORMATION

重要安全信息

neffy contains epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life-threatening, can happen in minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or other unknown causes.

neffy 含有肾上腺素，这是一种用于治疗过敏紧急情况（过敏性休克）的药物。过敏性休克可能危及生命，可能在几分钟内发生，并且可能由叮咬和螫刺昆虫、过敏注射、食物、药物、运动或其他未知原因引起。

Always carry two neffy nasal sprays with you because you may not know when anaphylaxis may happen and because you may need a second dose of neffy if symptoms continue or come back. Each neffy contains a single dose of epinephrine. neffy is for use in the nose only.

始终随身携带两支neffy鼻喷雾，因为你可能不知道何时会发生过敏性休克，并且如果症状持续或复发，你可能需要第二剂neffy。每支neffy含有一剂肾上腺素。neffy仅限用于鼻腔。

Use neffy right away, as soon as you notice symptoms of an allergic reaction. If symptoms continue or get worse after the first dose of neffy, a second dose is needed. If needed, administer a second dose using a new neffy in the same nostril starting 5 minutes after the first dose. Get emergency medical help for further treatment of the allergic emergency (anaphylaxis), if needed after using neffy..

一旦发现过敏反应症状，立即使用neffy。如果在第一次服用neffy后症状持续或恶化，则需要第二次剂量。如有必要，在第一次给药后5分钟，使用新的neffy在同一鼻孔给予第二次剂量。使用neffy后，如有需要，获取紧急医疗帮助以进一步治疗过敏紧急情况（过敏性休克）。

Tell your healthcare provider if you have underlying structural or anatomical nasal conditions, about all the medicines you take, and about all your medical conditions, especially if you have heart problems, kidney problems, low potassium in your blood, Parkinson's disease, thyroid problems, high blood pressure, diabetes, are pregnant or plan to become pregnant, or plan to breastfeed..

告诉您的医疗保健提供者您是否有潜在的结构性或解剖性鼻腔状况、您所服用的所有药物以及您的所有健康状况，特别是如果您有心脏问题、肾脏问题、血液中钾含量低、帕金森病、甲状腺问题、高血压、糖尿病、怀孕或计划怀孕，或计划母乳喂养。

Tell your healthcare provider if you take or use other nasal sprays or water pills (diuretics) or if you take medicines to treat depression, abnormal heart beats, Parkinson's disease, heart disease, thyroid disease, medicines used in labor, and medicines to treat allergies. neffy and other medications may affect each other, causing side effects.

告诉您的医疗保健提供者您是否使用其他鼻喷雾剂或利尿剂（水丸），或者您是否服用治疗抑郁症、心律失常、帕金森病、心脏病、甲状腺疾病、用于分娩的药物以及治疗过敏的药物。Neffy和其他药物可能相互影响，导致副作用。

neffy may affect the way other medicines work, and other medicines may affect how neffy works..

neffy可能影响其他药物的作用，其他药物也可能影响neffy的作用。

neffy may cause serious side effects. If you have certain medical conditions or take certain medicines, your condition may get worse, or you may have more or longer lasting side effects when you use neffy.

neffy可能会引起严重的副作用。如果您有某些健康状况或正在服用某些药物，使用neffy时您的病情可能会加重，或者您可能会出现更多或持续时间更长的副作用。

Common side effects of neffy include: nasal discomfort, headache, throat irritation, chest and nasal congestion, feeling overly excited, nervous or anxious, nose bleed, nose pain, sneezing, runny nose, dry nose or throat, tingling sensation, including in the nose, feeling tired, dizziness, nausea, and vomiting..

Neffy的常见副作用包括：鼻部不适、头痛、喉咙刺激、胸闷和鼻塞、感觉过度兴奋、紧张或焦虑、流鼻血、鼻痛、打喷嚏、流鼻涕、鼻子或喉咙干燥、刺痛感（包括鼻子内）、疲倦、头晕、恶心和呕吐。

Tell your healthcare provider if you have any side effects that bother you or that do not go away after using neffy.

使用Neffy后，如果出现任何困扰您的副作用或副作用持续不退，请告知您的医疗保健提供者。

These are not all of the possible side effects of neffy. Call your healthcare provider for medical advice about side effects. To report side effects, contact ARS Pharmaceuticals Operations, Inc. at

这些并非 neffy 的所有可能副作用。如需了解有关副作用的医疗建议，请联系您的医疗服务提供者。要报告副作用，请联系 ARS Pharmaceuticals Operations, Inc.

1-877-MY-NEFFY (877-696-3339)

1-877-MY-NEFFY（877-696-3339）

or the FDA at 1-800-FDA-1088 or

或致电FDA 1-800-FDA-1088 或者

www.fda.gov/medwatch

www.fda.gov/medwatch

.

。

Please see the full

请参阅完整内容

Prescribing Information

处方信息

and

和

Patient Information

患者信息

for

为了

neffy

内菲

.

。

About Type I Allergic Reactions Including Anaphylaxis

关于包括过敏性休克在内的I型过敏反应

Type I allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine auto-injectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation.

I型过敏反应是严重的、可能危及生命的事件，可在接触过敏原后数分钟内发生，需要立即使用肾上腺素进行治疗，这是FDA批准的唯一用于这些反应的药物。虽然肾上腺素自动注射器已被证明非常有效，但有充分记录的局限性导致许多患者和护理人员在紧急情况下延迟或未给予治疗。

These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 40 million people in the United States who experience Type I Allergic reactions. Of this group, over the last three years, approximately 20 million people have been diagnosed and treated for severe Type I allergic reactions that may lead to anaphylaxis, but (in 2023, for example) only 3.2 million filled their active epinephrine auto-injector prescription, and of those, only half consistently carry their prescribed auto-injector.

这些局限性包括对针头的恐惧、缺乏便携性、与针头相关的安全问题、设备的可靠性不足以及复杂性。美国大约有4000万人经历过I型过敏反应。在这一群体中，过去三年里，约有2000万人被诊断出患有严重的I型过敏反应并接受治疗，这种反应可能引发过敏性休克，但（例如在2023年）只有320万人填写了他们的肾上腺素自动注射器处方，而其中只有一半人始终随身携带他们被处方的自动注射器。

Even if patients or caregivers carry an auto-injector, more than half either delay or do not administer the device when needed in an emergency..

即使患者或护理人员携带自动注射器，在紧急情况下需要使用时，也有一半以上的人会延迟或不使用该设备。

About ARS Pharmaceuticals, Inc.

关于ARS制药公司

ARS Pharmaceuticals is a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis. The Company is commercializing neffy

ARS Pharmaceuticals是一家生物制药公司，致力于帮助高危患者及其护理人员更好地保护患者免受可能导致过敏性休克的过敏反应。该公司正在推广neffy。

®

®

(trade name EUR

（商品名 EUR

neffy

内菲

®

®

in the EU) (previously referred to as ARS-1), an epinephrine nasal spray indicated in the U.S. for emergency treatment of Type I allergic reactions, including anaphylaxis, adult and pediatric patients 4 years of age and older who weigh 15 kg or greater, and in the EU for emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products, and other allergens as well as idiopathic or exercise induced anaphylaxis in adults and children who weigh 30 kg or greater.

在欧盟）（之前称为ARS-1），一种肾上腺素鼻喷剂，在美国适用于紧急治疗I型过敏反应，包括过敏性休克，4岁及以上且体重15公斤或以上的成人和儿童患者；在欧盟适用于因昆虫叮咬或蜇伤、食物、药物及其他过敏原引起的过敏反应（过敏性休克）的紧急治疗，以及体重30公斤或以上的成人和儿童的特发性或运动诱发的过敏性休克。

For more information, visit .

有关更多信息，请访问 。

www.ars-pharma.com

www.ars-pharma.com

.

。

Forward Looking Statements

前瞻性声明

Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to: the expectation that

本新闻稿中的陈述若非纯粹历史性内容，则根据1995年《私人证券诉讼改革法案》属于“前瞻性陈述”。这些陈述包括但不限于：预期

neffy

内菲

will save lives; the effectiveness of

将挽救生命；其有效性

neffy

尼菲

;

；

neffy

内菲

Connect’

连接’

s ability to help patients and HCPs access financial support and medication fulfillment services; ARS Pharmaceuticals’ commercial coverage goals and the timing thereof; the expected timing for product availability of

帮助患者和医疗保健提供者获取财务支持和药品配送服务的能力；ARS Pharmaceuticals的商业覆盖目标及其时间安排；产品上市的预期时间；

neffy

内菲

1 mg;

1毫克；

neffy’s

内菲的

ability to improved health outcomes and quality of life;

改善健康结果和生活质量的能力；

neffy’s

尼菲的

shelf life and its effectiveness after being subject to extreme temperatures; and other statements that are not historical fact. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipate,” “expects,” “if,” “may,” “potential,” “on track to,” “plans,” “will,” “would,” and similar expressions are intended to identify forward-looking statements.

保质期及其在极端温度下的有效性；以及其他非历史事实的陈述。由于此类陈述受到风险和不确定性的制约，实际结果可能与这些前瞻性陈述所表达或暗示的结果有重大差异。诸如“预期”、“预计”、“如果”、“可能”、“潜在”、“有望实现”、“计划”、“将”、“会”等词语及类似表述旨在识别前瞻性陈述。

These forward-looking statements are based upon ARS Pharmaceuticals’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation: potential safety and other complications from .

这些前瞻性声明基于ARS制药公司的当前预期，涉及的假设可能永远不会实现或可能被证明是错误的。实际结果和事件的时间可能会因各种风险和不确定性而与这些前瞻性声明中的预期存在重大差异，其中包括但不限于：潜在的安全性及其他并发症。

neffy

内菲

; the ability to maintain regulatory approval for

；维持监管批准的能力

neffy

内菲

in its currently approved indications the scope, progress and expansion of developing and commercializing

在其目前获批的适应症范围内，开发和商业化的范围、进展和扩展

neffy

尼菲

; the potential for governments and payors to delay, limit or deny coverage for

；政府和支付方可能延迟、限制或拒绝覆盖

neffy

内菲

; the size and growth of the market therefor and the rate and degree of market acceptance thereof vis-à-vis intramuscular injectable products; ARS Pharmaceuticals’ ability to protect its intellectual property position; and the impact of government laws and regulations. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption “Risk Factors” in ARS Pharmaceuticals’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the Securities and Exchange Commission (“SEC”) on November 13, 2024.

；因此其市场规模和增长以及市场接受率和程度相对于肌肉注射产品而言；ARS制药公司保护其知识产权地位的能力；以及政府法律法规的影响。可能导致实际结果与前瞻性陈述中所设想的结果存在重大差异的其他风险和不确定性，包含在ARS制药公司2024年11月13日向证券交易委员会（“SEC”）提交的截至2024年9月30日的季度Form 10-Q报告中的“风险因素”标题下。

These documents can also be accessed on ARS Pharmaceuticals’ website at www.ars-pharma.com by clicking on the link “Financials & Filings” under the “Investors & Media” tab..

这些文件也可以在ARS Pharmaceuticals的网站www.ars-pharma.com上访问，只需点击“投资者与媒体”标签下的“财务与文件”链接即可。

The forward-looking statements included in this press release are made only as of the date hereof. ARS Pharmaceuticals assumes no obligation and does not intend to update these forward-looking statements, except as required by law. For more information, visit www.ars-pharma.com, and follow us on LinkedIn and X..

本新闻稿中包含的前瞻性陈述仅截至本日期作出。ARS Pharmaceuticals不承担任何义务，并且无意更新这些前瞻性陈述，除非法律要求。欲了解更多信息，请访问www.ars-pharma.com，并在LinkedIn和X上关注我们。

References:

参考文献：

Source: ARS Pharmaceuticals, Inc.

来源：ARS Pharmaceuticals, Inc.

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