Clinical Data

PD data

neffy has a rapid effect on heart rate¹*^†

Effects on heart rate by epinephrine treatment

Heart rate response¹

A chart depicting the heart rate response (beats per minute) for neffy® (epinephrine nasal spray), needle-syringe epinephrine, and auto-injector epinephrine

neffy 2 mg
Epinephrine 0.3 mg
(needle-syringe)
Epinephrine 0.3 mg
(auto-injector)

neffy had an effect on heart rate within 1 minute

neffy 2 mg
Epinephrine 0.3 mg
(needle-syringe)
Epinephrine 0.3 mg
(auto-injector)

N=42

*The clinical meaning of PD responses observed in healthy subjects is unclear in the context of treating anaphylaxis.

^†PD analysis of a single dose of neffy 2 mg compared to 0.3 mg IM injection and 0.3 mg epinephrine (auto-injector) administered by caregivers in healthy volunteers.¹

BPM, beats per minute; HR, heart rate; IM, intramuscular; PD, pharmacodynamic.

neffy has a rapid effect on systolic
blood pressure¹*^†

Effects on systolic blood pressure by epinephrine treatment

Systolic blood pressure response¹

A chart depicting systolic blood pressure response (systolic blood pressure) for neffy® (epinephrine nasal spray), needle-syringe epinephrine, and auto-injector epinephrine

neffy 2 mg
Epinephrine 0.3 mg
(needle-syringe)
Epinephrine 0.3 mg
(auto-injector)

neffy had an effect on systolic blood pressure within 1 minute

neffy 2 mg
Epinephrine 0.3 mg
(needle-syringe)
Epinephrine 0.3 mg
(auto-injector)

N=42

*The clinical meaning of PD responses observed in healthy subjects is unclear in the context of treating anaphylaxis.

^†PD analysis of a single dose of neffy 2 mg compared to 0.3 mg IM injection and 0.3 mg epinephrine (auto-injector) administered by caregivers in healthy volunteers.¹

mm Hg, millimeters of mercury; SBP, systolic blood pressure.

neffy results from an oral food challenge (OFC) Phase III study^2‡

In a Phase III study of 15 Japanese patients aged 6 to 17 years, patients receiving neffy 2 mg (n=9) experienced²:

Symptom Relief

A green-teal gradient circle with a blue hand with a plus sign hovering above it in the center

100% of patients achieved symptom resolution with 1 dose

A green-teal gradient circle with a blue alarm clock that reads "5 min" on it in the center

Most patients experienced symptom relief within 5 minutes (range, 1-90 minutes)

A green-teal gradient circle with a blue alarm clock that reads "15 min" on it in the center

Symptoms resolved in a median time of 15 minutes (range, 1-90 minutes)

TEAEs

Regardless of relationship to OFC, 6 patients (66.7%) experienced ≥1 TEAE, with 5 patients (55.6%) having a TEAE that was considered treatment-related
2 patients (22.2%) had a TEAE that was considered induced by the OFC, none of which was considered treatment-related
No patients experienced serious adverse events during the study

No patients needed a second dose of neffy within 15 minutes of the first dose^§

^‡This study took place outside of the United States and was completed in Japan.

^§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.

TEAE, treatment-emergent adverse event.

PK data

neffy pharmacokinetic data

EPINEPHRINE PLASMA CONCENTRATION

neffy has comparable epinephrine levels¹*

A chart depicting epinephrine concentration over an hour after a single dose of neffy® (epinephrine nasal spray), needle-syringe epinephrine, and auto-injector epinephrine

N=42

*PK data are not indicative of efficacy and the clinical significance is not known.

^†Based on multiple clinical trials, the exposures in the first 10 minutes between neffy administration and IM injection were similar.¹

^‡A single dose of neffy 2 mg, 0.3 mg dose of IM epinephrine injection, and 0.3 mg epinephrine auto-injector were administered by caregivers to healthy adult subjects.¹

IM, intramuscular; PK, pharmacokinetic.

PATIENTS WITH RHINITIS

In patients with rhinitis, neffy has comparable epinephrine levels in similar times¹*^†

Epinephrine geometric mean plasma concentration-time profiles following 1 or 2 dose(s) in healthy adults with and without nasal allergen challenge induced rhinitis

Mean epinephrine concentration – single dose

A chart depicting the mean epinephrine concentration over an hour after a single dose of neffy® (epinephrine nasal spray) in those without nasal allergen challenge, neffy® (epinephrine nasal spray) in those with nasal allergen challenge, and needle-syringe epinephrine

Mean epinephrine concentration – two doses

A chart depicting the mean epinephrine concentration over an hour after two doses of neffy® (epinephrine nasal spray) in those without nasal allergen challenge, neffy® (epinephrine nasal spray) in those with nasal allergen challenge, and needle-syringe epinephrine

N=41

*PK data are not indicative of efficacy and the clinical significance is not known.

^†Study analyzed PK and PD of neffy 2 mg in seasonal allergy patients under normal conditions and nasal allergen challenge induced rhinitis compared with 0.3 mg IM injection.

IM, intramuscular; NAC, nasal allergen challenge; PD, pharmacodynamic; PK, pharmacokinetic.

Safety data

neffy was generally well tolerated across clinical trials¹

A hand holding neffy® (epinephrine nasal spray) in a green-teal gradient circle, including a callout of it not being the actual product size

Common adverse reactions in primary trials¹
Adverse reaction^\|\|	*neffy* 2mg (1 dose) (n=134)^¶	*neffy* 2mg (2 doses)^# (n=85)^¶
Throat irritation	2%	19%
Headache	6%	18%
Nasal discomfort	10%	13%
Feeling jittery	1%	11%
Tremor	0%	8%
Rhinorrhea	3%	7%

No serious TEAEs in all clinical trials^2-7
Most TEAEs were considered mild or moderate and resolved quickly^2-7
No risk of needle-related injuries such as lacerations, finger sticks, or blood vessel injections¹

^‖Data include subjects with nasal allergen challenge induced rhinitis.¹

^¶The trials used a crossover design and, therefore, the total number of subjects do not match the number of unique subjects (n=175).¹

^#Two nasal doses of neffy 2 mg were administered 10 minutes apart.¹

SUMMARY OF PRIMARY CLINICAL TRIALS

neffy 2 mg primary adult and pediatric studies^1,7

Study	Objectives	Study design	Product, dose, & administration	Patients (n)
EPI 15	PK and PD of *neffy* compared to IM and auto-injector injection dosed once and twice	6-arm, randomized, crossover study	Part 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 16	PK and PD of *neffy* under normal and NAC-induced rhinitis compared to IM injection	4-arm, randomized, partial crossover study	*neffy* 2 mg; *neffy* 2 mg w/ NAC-induced rhinitis; 0.3 mg IM; 0.5 mg IM	Seasonal allergy patients (36)
EPI 17	PK and PD of *neffy* with patient self-administration	2-arm, randomized, crossover study	*neffy* 2 mg (self-administration); 0.3 mg IM (medical staff administration)	Type I allergy patients (42)
EPI 10	PK and PD in pediatric type I allergy patients	Single-arm; single-dose	*neffy* 2 mg	Pediatric allergy patients (21)
EPI 18	PK and PD of *neffy* compared to IM in type I allergy patients with seasonal rhinitis	5-arm, randomized, crossover study	NAC: *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. Data on file. EPI-10 CSR. ARS Pharmaceuticals Operations, Inc. 2024. 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-17 CSR. ARS Pharmaceuticals Operations, Inc. 2022. 7. Data on file. EPI-18 CSR. ARS Pharmaceuticals Operations, Inc. 2024.

PD data

neffy has a rapid effect on heart rate¹*^†

Effects on heart rate by epinephrine treatment

neffy has a rapid effect on systolic
blood pressure¹*^†

Effects on systolic blood pressure by epinephrine treatment

neffy results from an oral food challenge (OFC) Phase III study^2‡

In a Phase III study of 15 Japanese patients aged 6 to 17 years, patients receiving neffy 2 mg (n=9) experienced²:

Symptom Relief

TEAEs

PK data