ARS Pharmaceuticals Showcases Intranasal Epinephrine Data at 2024 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting
SPRY 10.24.2024
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“The research being presented at the ACAAI Annual Scientific Meeting is part of the extensive body of knowledge that ARS has contributed on epinephrine administration through our comprehensive clinical research,” said
The complete list of ARS Pharmaceuticals’ poster presentations is below. Full posters can be viewed onlinehere.
| Poster Presentation #1 | |
| Time: | |
| Title: | “Cardiovascular Safety of Intramuscular and Intranasal Epinephrine Administration” |
| Authors: | |
| Abstract ID: | 8064 |
| ePoster ID: | R235 |
| Poster Presentation #2 | |
| Time: | |
| Title: | “Blood Pressure And Pulse Rate Increases, Without Concomitant Epinephrine Increases, During Acute Allergic Reactions” |
| Authors: | |
| Abstract ID: | 8065 |
| ePoster ID: | R236 |
| Poster Presentation #3 | |
| Time: | |
| Title: | “Successful Administration of ARS-1 (Intranasal Epinephrine) when Provided with a Two-Dose Carrying Case-Human Factor Study” |
| Authors: | |
| Abstract ID: | 8066 |
| ePoster ID: | R237 |
| Poster Presentation #4 | |
| Time: | |
| Title: | “Significant Differences in Pharmacokinetic Profiles Among Epinephrine Products-What is the Mechanism for Efficacy?” |
| Authors: | |
| Abstract ID: | 8067 |
| ePoster ID: | R238 |
| Poster Presentation #5 | |
| Time: | |
| Title: | “Pharmacokinetics And Pharmacodynamics Following Repeat Dosing of ARS-1 versus Intramuscular Injection During Allergic Rhinitis” |
| Authors: | |
| Abstract ID: | 8068 |
| ePoster ID: | R239 |
| Poster Presentation #6 | |
| Time: | |
| Title: | “ARS-1 Development, From Pharmacokinetics and Pharmacodynamics to Real-World Data in Pediatric Food Allergy Patients” |
| Authors: | |
| Abstract ID: | 8069 |
| ePoster ID: | R240 |
| Poster Presentation #7 | |
| Time: | |
| Title: | “HCP Interest in ARS-1, a Self-Administered Intranasal Epinephrine Device” |
| Authors: | |
| Abstract ID: | 8070 |
| ePoster ID: | R241 |
About Type I Allergic Reactions including AnaphylaxisType 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 due to food, venom or insect stings. Of those, only 3.3 million currently have an 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.
Aboutneffy®
neffy®is an intranasal epinephrine product for patients with Type I allergic reactions including food, medications, and insect bites that could lead to life-threatening anaphylaxis.
INDICATION AND IMPORTANT SAFETY INFORMATION FORneffy(epinephrine nasal spray)
INDICATION
neffy2 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 twoneffynasal sprays at all times. In the absence of clinical improvement or if symptoms worsen after initial treatment, administer a second dose ofneffyin the same nostril with a new nasal spray starting 5 minutes after the first dose.
neffyis 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 ofneffymay 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 inneffyshould not deter use.
neffymay alter nasal mucosa for up to 2 weeks after administration and increase systemic absorption of nasal products, includingneffy.
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 toneffymay 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 ofneffy. 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 orwww.fda.gov/medwatch.
For additional information onneffy, please see Full Prescribing Information at www.neffy.com.
About ARS Pharmaceuticals, Inc.
Forward-Looking StatementsStatements 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 significance of the results from ARS Pharmaceuticals’ studies; the needle-free profile ofneffypotentially increasing the likelihood that patients may both carryandadminister epinephrine; the potential market and demand forneffy; 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 “can,” “could,” “may,” “potential,” “will,” and similar expressions are intended to identify forward-looking statements. 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: the ability to obtain and maintain regulatory approval forneffy; potential safety and other complications fromneffy; the labelling forneffyin any future indication or patient population, if approved; the scope, progress and expansion of developing and commercializingneffy; the potential for payors to delay, limit or deny coverage forneffy; 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 June 30, 2024, filed with the Securities and Exchange Commission (SEC) on August 6, 2024. This and other documents
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Source: ARS Pharmaceuticals, Inc.