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)
INDICATIONneffy 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 INFORMATIONIt 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 ChakmaARS Pharmajustinc@ars-pharma.com
ARS Pharma Media Contact:Christy CurranSam
Brown Inc. 615.414.8668christycurran@sambrown.com
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