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Alexza announces initiation of Phase 2a study of inhaled alprazolam

According to Alexza Pharmaceuticals, a Phase 2a study of AZ-002 Staccato alprazolam for the treatment of epilepsy patients with acute repetitive seizures has been initiated. The study will take place in-clinic, though AZ-002 is being developed for home use to limit the occurrence of additional seizures after the patient has experienced one seizure and therefore to reduce hospital visits.

The company estimates that approximately 150,000 epilepsy patients in the US experience acute repetitive seizures.

Alexza Executive VP of R&D and Chief Scientific Officer James V. Cassella said, “Our team has been working with some of the leading opinion leaders in the field of epilepsy to finalize our development strategy for AZ-002. We believe that AZ-002, if approved, could greatly benefit epilepsy patients who experience seizure emergencies like ARS. In previous clinical studies where we have dosed more than 100 subjects, Staccato alprazolam demonstrated excellent dose-proportionality, exhibited a median Tmax (time to peak plasma concentration) of 2 minutes, and was safe and well-tolerated.”

Results are expected during the first half of 2015.

Read the Alexza press release.

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published on January 22, 2015

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