FDA PDUFA Date for Adasuve The FDA assigned a Prescription Drug User Fee Act (PDUFA) action date for Alexza Pharmaceuticals' New Drug Application (NDA) for ADASUVE for treatment of agitation associated with schizophrenia or bipolar disorder in adults of December 21. 2012.
Alexza Pharmaceuticals initiates Phase 2a study of AZ-002 in epilepsy Alexza Pharmaceuticals has initiated a Phase 2a study of AZ-002 - Staccato alprazolam -, which is being developed for the management of epilepsy in patients with acute repetitive seizures. ARS occurs in a subset of patients with epilepsy who regularly experience breakthrough seizures, despite treatment with a regular regimen of anti-epileptic drugs. Alexza expects to announce results from this study in 1H15.