FDA: Boehringer Ingelheim Corporation's Pradaxa Benefit Outweighs Bleeding Risk
Published: Dec 08, 2011
Alexza Pharmaceuticals Inc.'s (ALXA: News ) inhalation antipsychotic drug candidate Adasuve poses a significant risk of bronchospasm, particularly in patients with asthma and chronic obstructive pulmonary disease, according to FDA briefing documents posted online yesterday. Adasuve is a drug-device combination which uses Alexza's proprietary Staccato system to deliver the antipsychotic Loxapine into the patient's lungs. Alexza is seeking approval for Adasuve for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder. This is Adasuve's second go-around with the FDA.