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Alexza begins Phase IIa trial of AZ-002 to treat epilepsy patients

US-based Alexza Pharmaceuticals has started a Phase IIa trial of AZ-002 (Staccato alprazolam), which is being developed for the management of epilepsy in patients with acute repetitive seizures (ARS).

The in-clinic, randomized, placebo-controlled, double-blind Phase IIa trial will evaluate patients with epilepsy using the intermittent photo-stimulation model.

The trial’s primary aim is to evaluate the safety and the pharmacodynamic electroencephalographic effects of a single dose of AZ-002 at different dose strengths vs. placebo.

Data from this trial is expected to serve as the basis for dose selection in potential future efficacy and safety clinical trials and will be collected from three clinical trial sites.

Alexza executive vice-president of Research and Development and chief scientific officer James 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."

Acute repetitive seizures occur in a subset of patients with epilepsy who regularly experience breakthrough seizures, despite treatment with a regular regimen of anti-epileptic drugs.