CHMP recommends Adusive (Alexza/Ferrer)for control of agitation in Schizophrenia and Bipolar patients

Alexza Pharmaceuticals, Inc. and Grupo Ferrer Internacional, S.A., have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending that Adasuve (Staccato loxapine) be granted European Union centralized marketing authorization. The CHMP recommends that Adasuve be authorized in the EU for the rapid control of mild-to-moderate agitation in adult patients with Schizophrenia or Bipolar Disorder.

Patients should receive regular treatment immediately after control of acute agitation symptoms. The recommendation by the CHMP is that Adasuve should be administered only in a hospital setting under the supervision of a healthcare professional. Short-acting beta-agonist bronchodilator treatment should be available for treatment of possible severe respiratory side-effects, such as bronchospasm.