ARS Pharmaceuticals to Showcase Innovation and Present Data on neffy® (epinephrine nasal spray) at 2025 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Scientific Meeting
Oral presentation on an efficacy study conducted in Japanese patients comparing anaphylaxis symptoms during oral food challenge with neffy as the initial treatment compared to site historical data on intramuscular auto-injectors, antihistamines and inhalers; patients receiving neffy had lower symptom scores within 10 minutes, supporting neffy as a needle-free option for management of anaphylaxis
neffy was shown to be in the safe and efficacious range for children four years or older who weigh more than 15 kilograms
Findings in Chinese studies confirms U.S. data and bracketed pharmacokinetic (PK) and pharmacodynamic (PD) profiles, demonstrate neffy's comparable efficacy and safety under various conditions including self-administration, allergic rhinitis, infectious rhinitis, in allergy challenges and with repeat dosing, compared with intermuscular injection
SAN DIEGO, Feb. 18, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (NASDAQ:SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, announced today that nine presentations will be featured at the 2025 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Scientific Meeting, February 28 to March 3, in San Diego, California. The oral presentation and posters will feature data from a wide range of studies, including pharmacokinetics and pharmacodynamics of intranasal epinephrine under normal and various conditions, physiological responses between adults and children who are administered epinephrine, and the pre-treatment journey of patients with allergic conditions. In addition to the presentations, ARS Pharma will participate in and host a variety of onsite activities during the meeting.
"We look forward to sharing additional findings from our comprehensive clinical research program with the broader allergy community at AAAAI and expect that the data will continue to build on the existing robust data on the efficacy and safety of intranasal epinephrine administration," said Sarina Tanimoto, MD, PhD, Co-Founder and Chief Medical Officer of ARS Pharma the maker of neffy (epinephrine nasal spray), the first and only FDA-approved needle-free treatment for Type I allergic reactions, including anaphylaxis, in adults and children who weigh ≥30 kg (66 lbs.). "As one of the leading companies actively conducting research in this critical space, we remain committed to advancing the scientific knowledge base of epinephrine so we can contribute to the allergy community."
The complete list of presentations and meeting activities is below. Abstracts can be viewed at annualmeeting.aaaai.org. Attendees are encouraged to visit the ARS Pharma booth (#1315), oral and poster presentations as well as the product theatre to learn more about neffy.
| Oral Presentation – March 1, 2025 | |
| Time: | 2:45 p.m. - 2:55 p.m. PST |
| Title: | Superior Efficacy of Epinephrine Nasal Spray for the Relief of Symptoms Following an Oral Food Challenge |
| Speaker: | Kyohei Takahashi, MD, MPH, PhD |
| Room: | Convention Center, Upper Level, Room 6B |
| Poster ID: | 571 |
| Poster Presentations – March 1, 2025 | |
| Poster Presentation #1 | |
| Time: | 9:45 a.m. - 10:45 a.m. PST |
| Title: | Pharmacokinetics and Pharmacodynamics of Single Dose of Epinephrine Nasal Spray and Manual Intramuscular Injections via HCP and Self-administration in Chinese Subjects Under Normal Conditions |
| Authors: | Yun Liu, MD, Shumin Wang, PhD, Miao Yu, MD, PhD, Pingya Hu, MD, Richard Lowenthal, MSc, Sarina Tanimoto, MD, PhD |
| Poster ID: | 297 |
| Poster Presentation #2 | |
| Time: | 9:45 a.m. - 10:45 a.m. PST |
| Title: | Persistence to Treatment in Patients with Allergic Conditions Requiring Epinephrine Auto-Injector Prescription (EAI Rx) |
| Authors: | Autumn Burnette, MD, Raffi Tachdjian, MD, Nicole M. Chase, MD, Sarina Tanimoto, MD, PhD, Ayman Kafal, PhD, MPH |
| Poster ID: | 302 |
| Poster Presentation #3 | |
| Time: | 9:45 a.m. - 10:45 a.m. PST |
| Title: | Pharmacokinetics of Epinephrine Nasal Spray under Various Conditions |
| Authors: | David M. Fleischer, MD, John Oppenheimer, MD, David Bernstein, MD, Thomas B. Casale, MD, Jonathan M. Spergel, MD, Richard Lowenthal, MSc, Sarina Tanimoto, MD, PhD |
| Poster ID: | 290 |
| Poster Presentation #4 | |
| Time: | 9:45 a.m. - 10:45 a.m. PST |
| Title: | Difference in Physiology Between Adults and Children in Response to Epinephrine Administration |
| Authors: | Matthew J. Greenhawt, MD, David M. Fleischer, MD, Thomas B. Casale, MD, Michael A. Kaliner, MD, Neetu Talreja, MD, Richard Lowenthal, MSc, Sarina Tanimoto, MD, PhD |
| Poster ID: | 289 |
| Poster Presentation #5 | |
| Time: | 9:45 a.m. - 10:45 a.m. PST |
| Title: | Understanding the Pre-Treatment Journey of Patients with Allergic Conditions: Insights from Patient Demographics and Diagnostic Pathways |
| Authors: | Raffi Tachdjian, MD, Autumn Burnette, MD, Nicole M. Chase, MD, Sarina Tanimoto, MD, PhD, Ayman Kafal, PhD, MPH |
| Poster ID: | 291 |
| Poster Presentation #6 | |
| Time: | 9:45 a.m. - 10:45 a.m. PST |
| Title: | Pharmacokinetics and Pharmacodynamics of Single Dose of Epinephrine Nasal Spray and Manual Intramuscular Injection in Chinese Subjects Under Allergic Rhinitis Conditions |
| Authors: | Jianting Wang, MD, PhD, Shumin Wang, PhD, Miao Yu, MD, PhD, Jiaowei Lu, MD, Richard Lowenthal, MSc, Sarina Tanimoto, MD, PhD |
| Poster ID: | 318 |
| Poster Presentation #7 | |
| Time: | 9:45 a.m. - 10:45 a.m. PST |
| Title: | Total Nasal Symptom Scores Remain Consistent in Response to Repeated Nasal Allergen Challenges |
| Authors: | Anne K. Ellis, MD, Michael A. Kaliner, MD, Carlos A. Camargo, Jr., MD, DrPH, John Oppenheimer, MD, David Bernstein, MD, Thomas B. Casale, MD, Richard Lowenthal, MSc, Sarina Tanimoto, MD, PhD |
| Poster ID: | 483 |
| Poster Presentation #8 | |
| Time: | 9:45 a.m. - 10:45 a.m. PST |
| Title: | Pharmacokinetics and Pharmacodynamics of Repeat Dose of Epinephrine Nasal Spray and Manual Intramuscular Injection in Chinese Subjects Under Normal Conditions |
| Authors: | Shumin Wang, PhD, Jianting Wang, MD, PhD, Miao Yu, MD, PhD, Jiaowei Lu, MD, Richard Lowenthal, MSc, Sarina Tanimoto, MD, PhD |
| Poster ID: | 317 |
| Onsite Activities | |
| Joint Congress Opening Ceremony and Welcome Reception | |
| Date: | February 27, 2025 |
| Time: | 4:15 p.m. - 5:45 p.m. PST |
| Location: | Convention Center - Ground Level Room 6A |
| Non-CME Corporate Forum (Product Theatre) | |
| Date: | February 27, 2025 |
| Time: | 6:30 p.m. - 8:30 p.m. PST |
| Location: | Marriott Marquis San Diego Marina - North Tower, Lobby Level Grand Ballroom Salon 4 |
| Exhibit Booth | |
| Date: | February 28-March 2, 2025 |
| Location: | #1315 |
About neffy®
neffy is an intranasal epinephrine product for patients with Type I allergic reactions due to insect stings or bites, foods, medicinal products, other allergens, as well as idiopathic or exercise induced anaphylaxis that could lead to life-threatening anaphylaxis.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR neffy (epinephrine nasal spray)
INDICATION
neffy 2 mg is indicated for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 30 kg or greater.
IMPORTANT SAFETY INFORMATION
It is recommended that patients are prescribed and have immediate access to two neffy nasal sprays at all times. In the absence of clinical improvement or if symptoms worsen after initial treatment, administer a second dose of neffy in the same nostril with a new nasal spray starting 5 minutes after the first dose.
neffy is for use in the nose only.
Advise patients when to seek emergency medical assistance for close monitoring of the anaphylactic episode and in the event further treatment is required.
Absorption of neffy may be affected by underlying structural or anatomical nasal conditions.
Administer with caution to patients who have heart disease; epinephrine may aggravate angina pectoris or produce ventricular arrhythmias. Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or taking cardiac glycosides, diuretics, or anti-arrhythmics.
The presence of a sulfite in neffy should not deter use.
neffy may alter nasal mucosa for up to 2 weeks after administration and increase systemic absorption of nasal products, including neffy.
Patients with certain medical conditions or who take certain medications for allergies, depression, thyroid disorders, diabetes, and hypertension, may be at greater risk for adverse reactions.
Epinephrine can temporarily exacerbate the underlying condition or increase symptoms in patients with the following: hyperthyroidism, Parkinson's disease, diabetes, renal impairment. Epinephrine should be administered with caution in patients with these conditions, including elderly patients and pregnant women.
Adverse reactions to neffy may include throat irritation, intranasal paresthesia, headache, nasal discomfort, feeling jittery, paresthesia, fatigue, tremor, rhinorrhea, nasal pruritus, sneezing, abdominal pain, gingival pain, hypoesthesia oral, nasal congestion, dizziness, nausea, and vomiting.
These are not all of the possible side effects of neffy. To report suspected adverse reactions, contact ARS Pharmaceuticals Operations, Inc. at 1-877-MY-NEFFY (877-696-3339) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For additional information on neffy, please see Full Prescribing Information at www.neffy.com.
About Type I Allergic Reactions Including Anaphylaxis
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. 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 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. 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.
About ARS Pharmaceuticals, Inc.
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® 2 mg (trade name EURneffy® 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, in adult and pediatric patients who weigh 30 kg or greater, and in the EU for emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products, other allergens, as well as idiopathic or exercise induced anaphylaxis in adults and children who weigh 30 kg or greater. For more information, visit www.ars-pharma.com.
ARS Pharma Investor Contact:
Justin Chakma
ARS Pharma
[email protected]
ARS Pharma Media Contact:
Christy Curran
Sam Brown Inc.
615.414.8668
[email protected]
