Neffy® Achieves Primary Goals and Prompts Quick Relief in Phase 2 Urticaria Trial

ARS Pharmaceuticals, Inc., a biopharmaceutical firm, has unveiled promising results from a phase 2 study of neffy, an epinephrine nasal spray, for the treatment of chronic spontaneous urticaria. The study, which focused on patients who continued to experience flares despite ongoing medication, demonstrated significant improvements in symptoms such as itchiness, hives, and redness within minutes of neffy administration. The drug was found to be well-tolerated with mild to moderate side effects, primarily nasal discomfort.

The EPI-U01 trial was a randomized, placebo-controlled, cross-over study that included 18 adult patients. Participants, who had flares with severity scores of at least 2 on a 3-point scale while on antihistamines or Xolair, were given either 1 mg or 2 mg of neffy or a placebo. The results indicated that the 1 mg dose was as effective as the 2 mg dose, suggesting that the lower dosage could be sufficient for therapeutic effects.

Urticaria, characterized by itchy hives and angioedema, affects approximately 5 million people annually in the United States. Current treatments, primarily antihistamines, are ineffective for a significant portion of chronic cases. Neffy's rapid symptom relief offers a potential alternative for these patients, allowing for acute flare management at home, thus improving their quality of life.

ARS Pharma plans further studies in 2024, with an outpatient trial for patients on antihistamines experiencing frequent flares, potentially leading to a pivotal study in 2025. The company anticipates FDA approval for neffy in treating allergic reactions, including anaphylaxis, in the latter half of 2024.

Neffy's development is significant for Type I allergic reactions, which require immediate epinephrine treatment. Despite the effectiveness of epinephrine autoinjectors, many patients and caregivers hesitate to use them due to various concerns. Neffy could provide a more accessible and less intimidating option for managing severe allergic reactions.

ARS Pharmaceuticals is committed to empowering patients and caregivers to better protect against severe allergic reactions. The company's focus on developing neffy reflects its dedication to addressing unmet needs in the management of life-threatening allergic conditions.