ARS Pharmaceuticals, Inc. (SPRY) ARS Pharmaceuticals neffy (epinephrine nasal spray) FDA Approval Conference Call Transcript

ARS Pharmaceuticals' neffy (Epinephrine Nasal Spray) FDA Approval

Key Highlights:

• FDA Approval: On August 9, 2024, the FDA approved neffy, the first needle-free epinephrine nasal spray for the emergency treatment of type 1 allergic reactions, including anaphylaxis, in adults and children weighing 30 kilograms or more.

• Product Features:

  • Size and Portability: Similar in size to an earbud case, making it easy to carry discreetly.
  • No Needle: Eliminates the fear and risk associated with needles, reducing the risk of accidental self-injection.
  • Ease of Use: Simple to use and consistent in dosing, even by passerbys (non-experts).
  • Temperature Stability: Completed stability studies at 122°F for up to three months and freeze-thaw studies showing robust performance under extreme conditions.
  • Long Shelf Life: 30-month shelf life compared to 18 months for traditional epinephrine auto-injectors.

• Clinical Benefits:

  • Improved Outcomes: Better clinical outcomes, fewer hospitalizations, and improved quality of life.
  • Early Administration: Can be administered quickly and confidently at the first signs of symptoms, potentially preventing severe anaphylaxis.
  • Accessibility: Potential for use in public places like restaurants and airplanes, enhancing accessibility.

• Label and Post-Marketing Commitments:

  • Indications: Approved for the emergency treatment of type 1 allergic reactions, including anaphylaxis, in adults and children weighing 30 kg or more.
  • Dosage: Single 2-milligram spray in either nostril; a second dose can be administered starting after 5 minutes if clinical improvement is not seen.
  • Post-Marketing Requirements:
    • EPI-10 Study: File 1-milligram data for pediatric patients (15-30 kg) within weeks of the conference call.
    • Registry Study: Collect safety data in patients having anaphylactic episodes following oral allergy challenges, immunotherapy, or allergy shots.
    • Pharmacokinetic Profile: Ensures the PK profile is within the range of other injection products, ensuring efficacy and safety.

• Market Impact:

  • Unmet Medical Need: Addresses the significant unmet medical need among 80-90% of patients who do not carry or use their epinephrine auto-injectors as prescribed.
  • Patient Confidence: Enhances patient confidence and adherence, reducing the risk of delays and improper use.

Overall, neffy represents a significant advancement in the treatment of severe allergic reactions, offering a safer, more accessible, and easier-to-use solution for patients and caregivers.