ARS Pharmaceuticals (SPRY) FDA Announcement summary

Introduction and purpose

• FDA approved neffy, the first and only needle-free epinephrine nasal spray for emergency treatment of Type I allergic reactions, including anaphylaxis, in adults and children weighing 30 kg or more.

• neffy is designed to address limitations of current injectable treatments, aiming to improve patient adherence, rapid administration, and reduce anxiety.

Details of approval or decision

• neffy 2 mg is indicated for emergency use in adults and children ≥30 kg, dosed as a single spray in either nostril, with a second dose after five minutes if needed.

• No contraindications or boxed warnings; label removes injection-related warnings and includes simple precautions for nasal anatomical conditions.

• Approval is based on five primary registration studies and multiple supportive studies.

• Supplemental NDA for 1 mg pediatric dose (15–30 kg) to be filed by end of Q3 2024.

Impact on industry and stakeholders

• neffy offers a needle-free, portable, and user-friendly alternative, expected to improve adherence, outcomes, and willingness to carry emergency medication.

• Market research shows high dissatisfaction with current injectors and strong interest in neffy among patients and providers.

• Broad insurance coverage and affordability initiatives, including $25 co-pay for most insured patients, are expected to facilitate access.

• Potential for use in public spaces due to safety and ease of administration, with advocacy from patient groups and healthcare professionals.

• Multi-billion dollar market opportunity, with global expansion and additional indications planned.