Alexza falls as reviewers identify Adasuve safety concerns

Alexza Pharmaceuticals Inc. (NASDAQ:ALXA) fell $0.47 (47%) to $0.52 on Thursday after FDA reviewers said inhaled antipsychotic Adasuve loxapine poses a "significant" risk of bronchospasm, particularly in patients with preexisting airway disease. The comments were included in briefing documents posted ahead of Monday's Psychopharmacologic Drugs Advisory Committee meeting to discuss an NDA for Adasuve to treat agitation in patients with schizophrenia or bipolar disorder. The reviewers noted that even with adequate screening for pulmonary risk factors, some patients will require respiratory support after dosing, and some will be at risk for respiratory failure and death.

Reviewers said that Alexza's proposed REMS -- which includes monitoring patients for an hour after dosing -- would not "sufficiently mitigate the serious patient outcomes" resulting from bronchospasm associated with Adasuve. ...