EC approves Adasuve

The European Commission approved an MAA for Adasuve Staccato loxapine from Alexza Pharmaceuticals Inc. (NASDAQ:ALXA) to treat mild to moderate agitation in adults with schizophrenia or bipolar disorder. The approval requires that patients receive regular treatment immediately after control of acute agitation symptoms, and that Adasuve be administered only under supervision in a hospital setting that has access to a short-acting beta agonist bronchodilator treatment for bronchospasms. Alexza's European commercialization partner Grupo Ferrer Internacional S.A. (Barcelona, Spain) plans to launch the product -- loxapine delivered by the Staccato system inhaler -- in the EU in 3Q13.

In December, FDA approved Adasuve to treat acute agitation in adults with schizophrenia or bipolar disorder. The drug was approved with a 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 plans to launch Adasuve in the U.S. in 3Q13 (see BioCentury Extra, Dec. 21, 2012). ...