Product information and disease description Place of product in therapy Approaches to treatment Current treatment options and standard of care

Intranasal epinephrine

8 evidence topics · 5 sources

Approval of the first needle-free epinephrine product

“ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, today announced that the U.S. Food and Drug Administration (FDA) approved neffy® (epinephrine nasal spray) 2 mg for the treatment of Type I Allergic Reactions, including anaphylaxis, in adults and children who weigh ≥30 kg (66 lbs.).” (opens the source at this quote in a new tab)
“The approval of neffy is based on data from five primary registration studies with a 2 mg intranasal dose of epinephrine. These primary clinical trials were supported by numerous pilot and supportive studies. neffy met all defined clinical endpoints and its pharmacokinetic (PK) and pharmacodynamic (PD) data were within the range of approved epinephrine injection products.” (opens the source at this quote in a new tab)

Approved indication and dosing of epinephrine nasal spray

“Neffy is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 15 kg or greater.” (opens the source at this quote in a new tab)
“In the absence of clinical improvement or if symptoms worsen after the initial treatment, a second dose of neffy may be administered in the same nostril with a second nasal spray starting 5 minutes after the first dose.” (opens the source at this quote in a new tab)
“It is recommended that patients are prescribed and have immediate access to two neffy nasal sprays at all times.” (opens the source at this quote in a new tab)

Nasal spray dose by weight band

Patient weight	Quoted dosage
30 kg or greater	“One spray of neffy 2 mg”
15 kg to less than 30 kg	“One spray of neffy 1 mg”

Labeled restriction in structural or anatomical nasal conditions

“Clinical pharmacology studies with neffy included subjects with history of allergic rhinitis, but did not include subjects with underlying structural and anatomical nasal conditions (e.g., polyps, history of nasal fractures or injuries, or history of nasal surgery). Absorption of neffy may be affected by underlying structural and anatomical nasal conditions. Consider use of other epinephrine products given by other routes of administration for patients with underlying structural or anatomical nasal conditions.” (opens the source at this quote in a new tab)

Storage and freezing constraints for the nasal spray

“Store at 68°F to 77°F (20°C to 25°C). Excursions permitted up to 122°F (50°C).” (opens the source at this quote in a new tab)
“Do not freeze. Neffy freezes below 5°F (-15°C). If neffy is frozen, it will not deliver epinephrine. Neffy may be used if it has been thawed after being previously frozen.” (opens the source at this quote in a new tab)

Pharmacokinetic and pharmacodynamic basis of the evidence for intranasal epinephrine

“Evaluating the efficacy of nasal epinephrine in Type I allergic reactions is challenging due to ethical and practical constraints that make randomized controlled trials difficult to conduct.” (opens the source at this quote in a new tab)

Comparison of intranasal epinephrine with injected epinephrine

“Notably, its nasal absorption is not affected by simultaneous upper respiratory infections, which supports its practical use.” (opens the source at this quote in a new tab)
“New alternatives, such as intranasal and sublingual adrenaline devices, are being developed to improve access and minimize hesitation in treatment.” (opens the source at this quote in a new tab)

Absence of a clinical evidence base for noninjectable routes at the time of the 2023 update

“This practice parameter addresses only injectable epinephrine; noninjectable routes of administration have been developed and have been reported to have favorable pharmacokinetic and pharmacodynamic profiles, but no clinical evidence base was available at the time of the development of this practice parameter.” (opens the source at this quote in a new tab)