Staccato loxapine regulatory update

Alexza plans to resubmit an NDA for Staccato loxapine (AZ-004) to treat agitation in patients with schizophrenia or bipolar disorder on Aug. 8 instead of in July as previously planned. The resubmission will include data from a human factors study, stability data from production batches, a REMS proposal and draft labeling. In a December meeting, FDA requested that Alexza provide a REMS and show how to identify patients at risk of developing pulmonary side effects, as well as a way to decide which patients should or should not be treated with Staccato loxapine. The company believes all of the issues in an October complete response letter are resolvable and expects a 6-month review period following resubmission. The agency indicated it would likely present the resubmission to an advisory committee (see BioCentury, Jan. 24). ...