FDA Panel Recommends Approval of Inhaled Antipsychotic
FDA Panel Recommends Approval of Inhaled Antipsychotic A US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) has recommended approval of inhaled loxapine ( Adasuve, Alexza Pharmaceuticals), as the first inhaled antipsychotic for agitation associated with schizophrenia and bipolar disorder (BD). The handheld, single-dose inhaler enables rapid drug delivery with greater comfort and convenience for patients who typically must be physically restrained and treated by injection. In October 2010, the FDA declined approval of the rapid-acting drug because of concerns regarding pulmonary toxicity, particularly in patients with asthma or chronic obstructive pulmonary disorder. If approved, inhaled loxapine will be administered once every 24 hours, in accordance with a proposed Risk Evaluation and Mitigation Strategy (REMS) that includes screening patients for respiratory risks and monitoring them for 1 hour after treatment. However, it may be ...