FDA approves Adasuve
FDA approved an NDA from Alexza Pharmaceuticals Inc. (NASDAQ:ALXA) for Adasuve Staccato loxapine to treat acute agitation in adults with schizophrenia or bipolar disorder. Alexza plans to launch the product -- loxapine delivered by the Staccato system inhaler -- in the U.S. in 3Q13. The Adasuve label includes a boxed warning of an increased risk of bronchospasm and increased mortality in elderly patients with dementia-related psychosis. Alexza was off $0.43 to $5.79 on Friday. In early after hours trading, the stock was off a further $0.62 (11%) to $5.17.
The approval also comes with an expected REMS, which includes provisions to ensure that the product is only administered in a healthcare facility that has access on-site to equipment and personnel trained to manage acute bronchospasm. Alexza has several postmarketing commitments for Adasuve, including an observational trial to evaluate Adasuve's real-world use and a clinical program to evaluate its safety and efficacy in agitated adolescent patients. ...