Alexza begins Phase 2a study of AZ-002 for ARS-related epilepsy management Alexza Pharmaceuticals.

ARS happens in a subset of patients with epilepsy who regularly experience breakthrough seizures, despite treatment with a regular regimen of anti-epileptic medications. We has been dealing with some of the leading opinion leaders in neuro-scientific 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 think that AZ-002, if approved, could greatly benefit epilepsy patients who encounter seizure emergencies like ARS. Dr. Cassella continued, In previous clinical research where we’ve dosed a lot more than 100 topics, Staccato alprazolam demonstrated superb dose-proportionality, exhibited a median Tmax of 2 minutes, and was well-tolerated and safe and sound.Vitamin K antagonist therapy was regarded as unsuitable for 1195 individuals because the risk of stroke was only moderate, as assessed by way of a score of just one 1 on the CHADS2 scale. There have been 2092 patients who didn’t want to take supplement K antagonists; in the case of 815 patients , this was the only real reason that vitamin K antagonist therapy was unsuitable. Early Termination of Study The data and safety monitoring committee examined the results of the first planned interim analysis of efficacy on February 19, 2010, of which time 104 events had occurred, and observed a treatment benefit and only apixaban for the principal outcome that exceeded 4 SD.