Urticaria is a skin disorder driven by mast cell degranulation and histamine release, which causes itchy wheals (hives) and angioedema, or both. In the United States, the annualized incidence is approximately 5 million cases (1.56 per 100,000).¹ ~40% of cases become chronic urticaria, which can last for several years before spontaneous remission occurs².

Antihistamines are the first-line therapy for treatment of urticaria but 50% of chronic urticaria cases still experience periodic exacerbations of symptoms despite use of antihistamines, and may benefit from an acute treatment for these periodic episodes³. These patients on stable therapy regimens can experience such exacerbations or flares multiple times a year⁴, including up to 8 to 9 HCP visits and 4 to 5 ER visits each year.⁵ Based on its mechanism of action and the clinical experience with epinephrine^6,7, an intranasal product has the potential to provide rapid and durable symptom relief for these acute exacerbations in a needle-free, easy-to-use form.