Alexza Pharmaceuticals has announced interim results from a Phase 2a study of AZ-002 inhaled alprazolam in epilepsy patients. Dose-related decreases in mean standardized photosensivity range (SPR), the study’s primary endpoint, were noted 2 minutes post inhalation for 2 of the 3 doses tested, the company said. According to Alexza, AZ-002 was also well tolerated with no serious adverse events reported.
Alexza announced the initiation of the study in January 2015 and said at the time that it expected results by mid-year. According to clinicaltrials.gov, the estimated enrollment is 6 patients.
The company is developing AZ-002 for the treatment of epilepsy in patients with acute repetitive seizures (ARS), and the 3 patients enrolled in the study so far had previously exhibited photoparoxysmal responses. The study is comparing three dose strengths of AZ-002 (0.5mg, 1.0mg and 2.0mg) to a placebo over a 6-week period.
Alexza Pharmaceuticals President and CEO Thomas B. King commented, “Our team has been working with some of the key thought leaders in the field of epilepsy to assess the clinical viability of AZ-002 for ARS. We are encouraged with the preliminary data from the interim analysis of our AZ-002 Phase 2a study. We believe that AZ-002, if developed and approved, could offer great benefit to epilepsy patients who experience seizure emergencies like ARS.”
Read the Alexza press release.
