Adasuve utilizes the company’s proprietary oral inhalation technology – Staccato system – which provides systemic delivery of a thermally-generated aerosol of loxapine.
The MAA seeks approval for the rapid control of agitation in adult patients with schizophrenia or with bipolar disorder.
Alexza Research and Development senior vice president James Cassella said in addition to information from the US NDA, their Adasuve MAA submission contains additional analysis of the primary efficacy data, and a comprehensive comparison of Staccato loxapine and other injectable drugs used to treat agitation.