Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it 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). ARS occurs in a subset of patients with epilepsy who regularly experience breakthrough seizures, despite treatment with a regular regimen of anti-epileptic drugs.
"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," said James V. Cassella, PhD, Executive Vice President, Research and Development, and Chief Scientific Officer of Alexza. "We believe that AZ-002, if approved, could greatly benefit epilepsy patients who experience seizure emergencies like ARS."
Dr. Cassella continued, "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."
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