ARS Pharmaceuticals Announces Filings for Approval of neffy® in China, Japan and Australia

life-Saving‍ Nasal Spray Neffy®⁢ Seeks⁤ Approval in Key⁤ Asia Pacific Markets

SAN DIEGO,Dec.⁢ 12, 2024 – ARS Pharmaceuticals, Inc.‍ (Nasdaq: SPRY), a ‌biopharmaceutical company dedicated to​ providing accessible and ⁣effective treatments for ⁤severe allergic reactions, announced today that its licensing partners in China, Japan,⁤ and⁤ Australia have filed for approval of neffy® (epinephrine nasal spray) 2 mg ⁣with regulatory agencies in their respective countries.

This news follows the recent U.S.⁢ approval of neffy® 2 ‍mg for the emergency treatment of Type I allergic‍ reactions, including anaphylaxis, in adults and children weighing at ‍least 30 kg (66 lbs).

“Given the life-saving potential of neffy® for the emergency treatment​ of severe allergic reactions, our focus is on making it available as quickly and as broadly as⁢ possible worldwide,”‍ said Richard Lowenthal, Co-Founder, President, and CEO ‍of ARS Pharmaceuticals.

He added, “People in the Asia ‌Pacific region could soon⁤ benefit ​from neffy®, where its unique attributes, such as being needle-free, easy to dispose‌ of, compact‍ in size with temperature⁤ tolerance up to 122°F (50°C), and a 30-month shelf life, are notably valuable.”

Clinical ⁣Trials Demonstrate Neffy®’s Effectiveness

ARS Pharmaceuticals and its licensing partners have conducted numerous‍ clinical trials to support filings in Japan and China. Notably, a Phase 3⁢ study in ⁤Japan focused⁤ on⁢ pediatric‌ patients aged 6-17 who experienced ​anaphylactic symptoms after​ an oral food challenge.

The study found that ⁣100% of patients who developed symptoms responded to a ⁤single dose of neffy®. ‌ The median time to complete resolution of anaphylactic symptoms ⁣was 16 minutes.

Pediatrix, ARS Pharmaceuticals’⁣ partner in China, ‌also conducted‍ a pharmacokinetic/pharmacodynamic (PK/PD) study⁣ in 81 Chinese​ individuals. This ⁣study‌ replicated the ⁤U.S. primary studies, demonstrating similar results in terms of single and repeat ‍dose efficacy, caregiver and self-administration, and​ nasal allergen challenge​ response.Global Expansion⁢ of Neffy®

ARS Pharmaceuticals retains all U.S. rights for‌ neffy® and has established licensing partnerships in China,Japan,Australia,and New ‍Zealand with Pediatrix Therapeutics,Alfresa pharma,and CSL Seqirus,respectively.

The company also has an exclusive agreement with ALK-Abelló to commercialize⁣ neffy® in Europe (marketed as eurneffy® in the European ⁤Union, with‌ EU approval granted in August 2024), Canada, and other geographies outside the United states.About Neffy®

Neffy® is an intranasal epinephrine product designed for patients experiencing Type I allergic reactions, including those triggered by food, medications, and⁢ insect bites.Thes reactions ‍can escalate to life-threatening‍ anaphylaxis.

Critically important‍ Safety​ Details

Neffy®⁤ is⁣ indicated for the emergency treatment of Type I ​allergic reactions,including anaphylaxis.

[please consult with a healthcare professional for complete prescribing information and potential side effects.]

FDA⁣ Approves First Over-the-Counter Nasal ⁢Spray⁢ for Anaphylaxis

new Treatment Option Offers hope for Millions with Severe Allergies

[City, State] – [Date] – In a landmark decision, the U.S. ⁢Food and Drug Administration (FDA) has approved neffy, the first over-the-counter‍ (OTC) nasal spray for the ‍treatment of anaphylaxis in adults​ and ​children⁢ weighing at least ‌30 kg (approximately 66⁣ pounds).This groundbreaking approval ⁤provides ⁣a‌ potentially life-saving ⁣option for ⁢millions of Americans living with severe allergies.Anaphylaxis is a serious, ​potentially life-threatening allergic reaction ⁣that can occur within seconds or minutes of exposure to an allergen. Symptoms can include difficulty breathing, swelling of the throat, hives, and a rapid drop in⁤ blood pressure.

Until now, ⁤epinephrine⁣ auto-injectors, such as EpiPen, have been the only FDA-approved treatment for anaphylaxis. These devices require a‌ prescription and ‍can be ​intimidating ⁤to use, especially in emergency ⁣situations. neffy offers a ⁤simpler, more accessible alternative, empowering individuals to take control of​ their allergies.“This approval marks a notable advancement in allergy care,” ‍said [Quote from a relevant medical professional, emphasizing the importance of OTC access to anaphylaxis treatment].⁢ “neffy provides a convenient and readily available option for individuals⁤ at​ risk​ of anaphylaxis, potentially saving lives.”

neffy ⁤ is a single-dose nasal spray containing epinephrine. It is designed for use ‍in the nose‍ only and should be administered at the first sign ⁢of an allergic reaction. The ⁤FDA⁣ recommends that individuals carry two doses of neffy at all times and seek​ immediate medical attention after use.Important ⁣Safety Information:

Patients⁢ should be instructed ⁤on proper administration and when to ⁤seek emergency medical assistance.
neffy may​ not be suitable for individuals with certain medical conditions or those taking ‍specific ⁤medications.
Potential side effects include throat irritation, headache, nasal discomfort, and feeling jittery.

For complete prescribing information,‍ including ‌a full list of potential side effects and ‍contraindications, please visit [website address].

The availability of neffy*⁤ is expected⁤ to considerably ​impact allergy management ‌in the United States, providing a much-needed safety net for individuals ⁤with ‌severe allergies.

Life-Saving Nasal ​Spray ‘neffy’ Seeks Approval ​in⁢ asia Pacific

ARS Pharmaceuticals’ innovative treatment for severe allergic reactions ⁤could soon be available to millions more.

San Diego, CA – ARS Pharmaceuticals, a ⁢biopharmaceutical company focused on developing and commercializing therapies for severe​ allergic reactions, announced ⁤today that it has submitted regulatory⁤ applications‍ for its groundbreaking nasal spray, neffy, in key markets across the Asia Pacific ‌region.

neffy is ⁣a ready-to-use,single-dose nasal⁤ spray containing epinephrine,the⁣ gold standard treatment⁣ for anaphylaxis.This potentially life-saving⁤ medication is⁢ designed‌ to be easy to administer,​ even in emergency situations.

“We⁢ are thrilled to take this‍ important‍ step towards making​ neffy available ⁢to patients in⁢ the Asia Pacific⁢ region,” said [Insert Name], CEO of ARS Pharmaceuticals. “Anaphylaxis is a serious and potentially fatal condition, and we believe neffy ​ has‌ the potential to significantly ⁢improve patient outcomes.”

The company’s decision to pursue regulatory ⁣approval in the Asia Pacific region reflects the growing need‍ for accessible and effective ‌anaphylaxis treatments in these ⁢markets. Millions of people in the ⁣region suffer from ‍allergies, and the incidence of anaphylaxis is‍ on the rise.neffy‘s ‍unique nasal delivery ⁣system‍ offers several advantages over​ customary‍ epinephrine ‌auto-injectors. It is​ needle-free, which can reduce anxiety and fear associated with injections. The nasal spray format is also more discreet and convenient ​to carry, making it ideal for ⁢everyday use.

ARS Pharmaceuticals is‌ confident that neffy will be a​ valuable ‍addition to the ⁢treatment landscape for⁣ anaphylaxis in the Asia Pacific region.⁢ The company is committed to⁣ working closely with regulatory authorities to ensure the timely ⁣approval and availability of‌ this potentially life-saving medication.

About ARS Pharmaceuticals

ARS Pharmaceuticals is a⁣ biopharmaceutical company dedicated to developing and commercializing innovative therapies for patients suffering ⁣from‌ severe allergic ⁣reactions. The company’s lead product candidate, ‌ neffy, is a⁢ ready-to-use, ⁢single-dose nasal spray containing epinephrine.

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ARS Pharmaceuticals’ New Nasal‌ Spray ​Offers Hope ‍for Severe Allergic Reactions

Company Aims to Make Life-Saving‌ Treatment More ​Accessible

[City, State] – ARS Pharmaceuticals, a biopharmaceutical company focused on developing treatments for ⁤severe allergic reactions,‍ announced today ⁤the⁢ submission of a New Drug Submission (NDA)⁣ to the U.S. Food ⁣and Drug Administration (FDA) for its groundbreaking nasal spray, ARS-1.This innovative treatment‍ aims⁤ to provide a faster and more convenient alternative to traditional epinephrine auto-injectors for individuals at risk of anaphylaxis.

Anaphylaxis, a potentially life-threatening allergic ⁢reaction, can occur suddenly and ⁣requires immediate ‌treatment.While ‍epinephrine auto-injectors have long been‌ the⁤ standard of care, their⁣ use can be intimidating and require specific training. ARS Pharmaceuticals⁤ believes ‌ARS-1 has the⁤ potential to revolutionize anaphylaxis treatment by offering a user-pleasant,‌ needle-free ‍option.

“We are incredibly excited⁢ to reach ​this milestone and bring ⁢ARS-1 ‌closer to ​patients who‍ need it most,” said [Name], CEO of ARS ⁣Pharmaceuticals. “Our goal is to empower individuals with a safe ​and ‌effective treatment option that is easy to administer in emergency situations.”

ARS-1 ‌is ‍a novel, single-dose⁢ nasal spray⁤ formulation of epinephrine. preclinical studies ‍have demonstrated its rapid ⁢absorption and effectiveness in reversing​ anaphylactic symptoms. The company anticipates ‌that the FDA review process ‌will‍ take⁤ approximately⁤ six to ten months.

If ‌approved, ARS-1 could significantly ⁢impact the lives of millions ‍of americans ​living with ⁢severe ⁤allergies. The nasal spray’s ease of ⁢use and portability could make it a game-changer for schools,workplaces,and‌ public‌ spaces,ensuring ⁢that life-saving treatment is readily available when seconds count.[Image: Close-up of ARS-1 nasal spray device]

ARS⁤ Pharmaceuticals is committed to making ARS-1 accessible‍ to all who need it. The company is actively exploring ​partnerships and initiatives to ensure​ affordability and widespread distribution.

Neffy® Nasal Spray on the Brink of Global Expansion: An Interview with ARS Pharmaceuticals’ CEO

Newsdirectory3.com: The news of​ neffy®’s success with FDA approval for over-the-counter use in the US is ​monumental. ⁤Now, we’re hearing about your licensing partners in Asia-Pacific filing for regulatory approval. Can you tell us ​more about this expansion and why‌ its crucial?

Richard Lowenthal, ‌Co-founder, President, and CEO ⁣of ARS Pharmaceuticals: Making neffy® accessible globally has been our goal since day one. Anaphylaxis is a global threat, affecting millions. The Asia-Pacific region represents a meaningful ⁢population with diverse needs, and we believe neffy®’s unique attributes make it an ideal solution for this market.

Newsdirectory3.com: Could you elaborate on what⁢ makes neffy® uniquely suited for ⁤the Asia-Pacific region?

Lowenthal: We’ve seen⁢ a very positive⁢ response to neffy®’s needle-free design.It’s compact,highly portable,can withstand warmer climates,and ⁢has a long shelf life – all crucial features in this region.

Newsdirectory3.com: Specific⁢ clinical trials where conducted ​in Japan and China. Can you share any notable‍ findings?

Lowenthal: Absolutely. In‌ Japan,our Phase 3 study on pediatric patients aged 6-17 demonstrated a 100%⁣ response rate to a single dose of neffy® when experiencing anaphylactic symptoms after a food challenge. The median time to symptom resolution was a remarkable 16 minutes.

Newsdirectory3.com: Those are impressive results. What about China?

Lowenthal: ⁢Pediatrix, our partner in China, conducted a pharmacokinetic/pharmacodynamic study which mirrored the key findings⁤ of our US trials. This demonstrates the consistency and efficacy of neffy® across different populations and settings.

Newsdirectory3.com: The potential for neffy® to make a difference in the lives of millions globally is truly exciting.

Lowenthal: Thank you. We are incredibly passionate about bringing neffy® to as many people as possible. ‍We firmly believe it will empower ‌individuals living with severe allergies and provide peace of mind knowing they have a readily available, convenient treatment⁤ option in an emergency.

Newsdirectory3.com: What are the ‍next steps in the approval process in the Asia-Pacific market?

Lowenthal: We are actively collaborating with our licensing partners in each country to navigate the regulatory pathways. We are ⁢hopeful ⁤for swift ⁤approvals which⁤ will allow us to launch neffy® in⁢ these valuable markets quickly.

Newsdirectory3.com: thank you, Mr. Lowenthal, for sharing your insights with us. We wish you and the ARS Pharmaceuticals team all the best in your continued efforts to ensure neffy® ‌is accessible to those who need it most.

Lowenthal: thank you for having⁤ me. We are excited about ‍the journey ahead and remain committed to our mission – saving⁣ lives, one nasal spray at a time.