The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion regarding Alexza Pharmaceutical’s marketing application for Adasuve Staccato loxapine for the treatment of agitation in patients with schizophrenia or bipolar disorder. Alexza filed the MAA in October 2011.
According to Alexza, CHMP recommended that the product should be used in hospital under medical supervision and that a rescue inhaler should be available in case the patient experiences bronchospasm.
Alexza Executive VP and Chief Scientific Officer James Cassella commented, “The recommendation for approval from CHMP moves us one step closer to bringing this novel treatment to patients with agitation. We believe that Adasuve may provide an important new therapeutic option as the first rapid and non-invasive treatment to address episodes of agitation.”
The company says that it expects a decision on the marketing authorization from the EC in the first quarter of 2013. In the US, Alexza refiled an NDA for Adasuve in June 2012.
Read the Alexza press release.
