Alexza Pharmaceuticals Inc. [NASDAQ: ALXA] expects an FDA decision under the Prescription Drug User Fee Act (PDUFA) on the approval status of ADASUVE, being developed for schizophrenia or bipolar I disorder in adults.
Alexza Pharmaceuticals is an emerging pharmaceutical company focused on the research, development and commercialization of novel proprietary products for the acute treatment of central nervous system (CNS) conditions. The Company’s product candidates are based on its proprietary technology, the Staccato drug delivery system, which vaporizes excipient-free drugs to allow for therapeutic onset that is comparable to IV administration in speed, but with greater ease and patient comfort.
ADASUVE™ (AZ-004: Staccato loxapine) is being developed for the acute treatment of agitation in patients with schizophrenia or bipolar disease, and has regulatory processes ongoing in both the United States and Europe. The drug has successfully completed two Phase III trials: a 344-patient trial for schizophrenia and a 314-patient trial for bipolar disorder. Both trials met primary and secondary endpoints. The Company’s overriding goals are to bring its first product, ADASUVE:Staccato loxapine, through the NDA and MAA review and approval processes while continuing to develop: AZ-104:Staccato loxapine (Phase IIb completed) for migraine headache; AZ-003:Staccato fentanyl (Phase I) for breakthrough pain; AZ-002:Staccato alprazolam (Phase I) for acute repetitive seizures; AZ-007:Staccato zalephon (Phase I) for insomnia and disrupted during sleep; and Staccato nicotine (Preclinical) for cessation of smoking.
There are over 3.5 million adults with schizophrenia and bipolar I disorder in the United States, 90% of whom suffer from agitation as a severe symptom.