Adusuve Staccato loxapine regulatory update
FDA issued a complete response letter for an NDA from Alexza for Adusuve Staccato loxapine (AZ-004) to treat agitation in patients with schizophrenia or bipolar disorder. According to the company, FDA said the primary clinical safety concern is related to data from three Phase I pulmonary safety studies in which dose-related post-dose decreases in forced expiratory volume in 1 second (FEV1) were observed in healthy subjects and in subjects with chronic obstructive pulmonary disease (COPD) and asthma. FDA also noted that the decreases in FEV1 were also observed in subjects who were administered device-only, placebo versions of AZ-004. FDA's Center for Devices and Radiological Health (CDRH) also requested a human factors study and related analysis to validate that the product can be used effectively in the proposed clinical setting. Alexza plans to meet with FDA to discuss the letter. AZ-004 is loxapine delivered by Alexza's Staccato system inhaler. ...