AZ-104

AZ-104 is an inhaled, low-dose formulation of loxapine delivered via Alexza Pharmaceuticals’ proprietary Staccato system for the acute treatment of migraine headache. The Staccato device rapidly vaporizes unformulated loxapine to form an aerosol for deep-lung inhalation, producing near–intravenous speed of systemic exposure with peak plasma levels within minutes. Loxapine is a tricyclic antipsychotic that acts as an antagonist at dopamine D2 receptors and serotonin 5-HT2 receptors, and this dual dopaminergic/serotonergic blockade has been investigated as a potential acute anti-migraine mechanism. AZ-104 has undergone Phase 1 dose-escalation and Phase 2a/2b proof-of-concept trials in migraineurs at doses as low as 0.625–5 mg, demonstrating rapid absorption and generally acceptable tolerability in early studies, and is positioned as a potential alternative for patients who have inadequate response or contraindications to triptans.[1][7]

Other names

Staccato loxapine low-dose