FDA rejects Alexza's anti-agitation loxapine inhaler, citing pulmonary safety concerns
This article was originally published in Scrip
Executive Summary
The US FDA has issued a complete response letter to Alexza Pharmaceuticals, and has declined to approve an NDA for AZ-004, an inhaled anti-agitation therapy which consists of the antipsychotic loxapine delivered via Alexza's Staccato system, a hand-held, single dose inhaler that delivers a drug aerosol to the deep lung.