Alexza Pharmaceuticals has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its new drug application (NDA) for AZ-004 (Staccato loxapine) submitted as Adusuve Staccato (loxapine) inhalation aerosol, 5mg and 10mg.
AZ-004 is being developed for the treatment of agitation in patients with schizophrenia or bipolar disorder.
In the CRL, the FDA has stated that their primary clinical safety concern was related to data from three Phase I pulmonary safety studies with AZ-004.
Additionally, the CRL also raised issues relating to the suitability of the studies undertaken by Alexza and certain other items relating to the FDA’s recently completed pre-approval manufacturing inspection.
Alexza Pharmaceuticals and Biovail Laboratories, a subsidiary of Valeant Pharmaceuticals, entered into a collaboration and license agreement in February 2010 for the US and Canadian rights to commercialize AZ-004.