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ORAL FOOD CHALLENGE (OFC)

100% of patients achieved symptom resolution with 1 dose2

Mean Grade Symptoms Chart Image
  • Patients had symptom relief as early as 1 minute2
  • Most patients experienced symptom relief within 5 minutes2
  • Symptoms resolved in a median time of 15 minutes2‡
  • neffy was demonstrated to be safe and tolerable with no serious adverse events observed during the study2,3

‡One patient developed a biphasic reaction 2 hours and 45 minutes following administration of neffy and was treated with epinephrine at the time of that reaction.2,3

Simulating real-world type I allergic
reactions with OFC

Overview:

This Phase 3, open-label study evaluated the efficacy and safety of a single dose of neffy (1.0 mg or 2.0 mg epinephrine) in Japanese pediatric patients with anaphylactic reactions (≥Grade 2)2

  • Clinical symptoms (skin/mucosa, digestive, respiratory, circulatory, nerves) were induced via OFC and graded per the Anaphylaxis Guideline2
  • neffy was administered based on weight: 15 to <30 kg: 1.0 mg; ≥30 kg: 2.0 mg2

Patients:

  • 15 Japanese pediatric patients (ages 6–17) with confirmed food allergy reactions (Grade 2+ in gastrointestinal, respiratory, or circulatory symptoms)2

Endpoints:

Primary endpoint2:
  • Improvement rate from baseline at 15 minutes or before alternative treatment*
    (Main symptom prioritization: cardiovascular > respiratory > gastrointestinal)
Selected secondary endpoints2:
  • Patients not requiring alternative treatment
  • Symptom grade over time
  • Time to resolution by organ system

*Improvement was defined as a decrease in the grade of each organ symptom by 1 or more compared to the pre-dose grade.2 Foods that were determined or suspected to be a causative allergen were divided into single doses or multiple doses and were recorded (ie, chicken egg, wheat, milk, peanut, cashew nut, walnut, soba, etc).2

Mild (Grade 1)

  • Localized redness, itching, or swelling (lip/eyelid)
  • Mild stomach pain, nausea, or single vomiting
  • Intermittent cough, nasal congestion, sneezing

Moderate (Grade 2)

  • Generalized redness, severe itching, face swelling
  • Severe stomach pain, repeated vomiting/diarrhea
  • Repetitive cough, wheezing, mild dizziness
  • Fast heart rate (tachycardia), mild low blood pressure

Severe (Grade 3) – EMERGENCY

  • Widespread swelling, trouble breathing, hoarseness
  • Continuous vomiting, loss of bowel control
  • Severe wheezing, difficulty swallowing, throat tightness, cyanosis
  • Severe low blood pressure, irregular heartbeat, cardiac arrest
  • Anxiety, fainting, loss of consciousness

neffy demonstrated a favorable safety profile in pediatric patients,
as well as adults, with no serious adverse events reported in the trials2,3,8

neffy 2 mg primary adult and pediatric studies1,7

StudyObjectivesStudy designProduct, dose, & administrationPatients (n)
EPI 15PK and PD of neffy compared to IM and auto-injector injection dosed once and twice6-arm, randomized, crossover studyPart 1: neffy 2 mg; 0.3 mg IM; auto-injector 0.3 mg IM
Part 2: neffy 2 mg twice (L/R);
neffy 2 mg twice (R/R);
auto-injector 0.3 mg twice		Healthy patients (42)
EPI 16PK and PD of neffy under normal and NAC-induced rhinitis compared to IM injection4-arm, randomized, partial crossover studyneffy 2 mg; neffy 2 mg
w/ NAC-induced rhinitis;
0.3 mg IM; 0.5 mg IM		Seasonal allergy patients (36)
EPI 17PK and PD of neffy with patient self-administration2-arm, randomized, crossover studyneffy 2 mg (self-administration); 0.3 mg IM (medical staff administration)Type I allergy patients (42)
EPI 10PK and PD in pediatric type I allergy patientsSingle-arm; single-doseneffy 2 mgPediatric allergy patients (21)
EPI 18PK and PD of neffy compared to IM in type I allergy patients with seasonal rhinitis5-arm, randomized, crossover studyNAC: neffy 2 mg twice (L/R);
0.3 mg IM twice
Rhinitis: 0.3 mg IM twice (L/R);
neffy 2 mg twice (L/R);
neffy 2 mg twice (R/R)		Type I allergy patients with seasonal rhinitis (41)

IM, intramuscular; L, left; NAC, nasal allergen challenge; PD, pharmacodynamic; PK, pharmacokinetic; R, right.

References: 1. neffy [prescribing information]. San Diego, CA: ARS Pharmaceuticals Operations, Inc. 2. Data on file. JP03 CSR. ARS Pharmaceuticals Operations, Inc. 2024.
3. Ebisawa M, Fleischer DM, Li HH, et al. neffy, epinephrine nasal spray, development, from pharmacokinetics and pharmacodynamics to real-world data in pediatric food allergy patients. Presented at the Annual Meeting of the American College of Allergy, Asthma and Immunology; October 24-28, 2024; Boston, MA. 4. Data on file. EPI-15 CSR. ARS Pharmaceuticals Operations, Inc. 2024. 5. Data on file. EPI-16 CSR. ARS Pharmaceuticals Operations, Inc. 2022. 6. Data on file. EPI-18 CSR. ARS Pharmaceuticals Operations, Inc. 2024. 7. Ellis AK, Casale TB, Kaliner M, et al. Development of neffy, an epinephrine nasal spray, for severe allergic reactions. Pharmaceutics. 2024;16(6):811. 8. Posner LS, Camargo Jr CA. Update on the usage and safety of epinephrine auto-injectors, 2017. Drug Healthc Patient Saf. 2017;9:9-18.

IMPORTANT SAFETY INFORMATION & INDICATION

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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.

INDICATION

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 15 kg or greater.

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.

Most common adverse reactions are nasal discomfort, headache, rhinorrhea, dizziness, nausea, vomiting, throat irritation, nasal congestion, paresthesia, sneezing, upper respiratory tract congestion, epistaxis, rhinalgia, nasal dryness, dry throat, fatigue, and feeling jittery.

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.

Please see full Prescribing Information for neffy.

IMPORTANT SAFETY INFORMATION & INDICATION

+

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.

INDICATION

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 15 kg or greater.

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.

Most common adverse reactions are nasal discomfort, headache, rhinorrhea, dizziness, nausea, vomiting, throat irritation, nasal congestion, paresthesia, sneezing, upper respiratory tract congestion, epistaxis, rhinalgia, nasal dryness, dry throat, fatigue, and feeling jittery.

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.

Please see full Prescribing Information for neffy.