---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-139053"
form_type: "8-K"
ticker: "SPRY"
cik: "0001671858"
company_name: "ARS Pharmaceuticals, Inc."
filed_at: "2023-05-09T23:59:59+00:00"
generated_at: "2026-06-15T09:23:38.967062+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-23-139053
- form_type: 8-K
- ticker: SPRY
- cik: 0001671858
- company_name: ARS Pharmaceuticals, Inc.
- filed_at: 2023-05-09T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1671858/000119312523139053/0001193125-23-139053-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1671858/000119312523139053/d415087d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-139053
- JSON: https://secwatch.observer/filing/0001193125-23-139053.json
- Plain text: https://secwatch.observer/filing/0001193125-23-139053.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.