ARS Pharma faces FDA AdCom on May 11 for neffy (intranasal epinephrine); PK/PD sufficiency debated

ARS Pharmaceuticals, Inc.

FDA AdCom to discuss whether PK/PD data for ARS-1 (intranasal epinephrine) sufficiently establish efficacy for anaphylaxis; meeting scheduled May 11, 2023.
Development program relies on PK/PD similarity to injection products rather than clinical efficacy trials; FDA questions translatability to anaphylaxis patients.
FDA notes PK/PD discrepancy: ARS-1 has lower epinephrine PK than EpiPen but higher/more sustained SBP/PR response; ARS argues this supports efficacy.
Proposed dose: 2 mg intranasal (one spray) for adults and children ≥30 kg, with optional second dose after 10 minutes if needed.
Human factors validation studies support usability; committee asked to weigh benefit-risk considering needle-free alternative to injectable epinephrine.

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