Alexza Pharmaceuticals of the USA and partner Ferrer are celebrating after getting the green light for their inhaled antipsychotic Adasuve.
The European Commission has granted marketing authorisation to Adasuve (loxapine) for the rapid control of mild-to-moderate agitation in adults with schizophrenia or bipolar disorder. The approval is based on two Phase III studies involving over 650 patients which showed that the drug demonstrated statistically significant reductions in agitation from baseline compared to placebo.
The approval requires that patients receive regular treatment immediately after control of acute agitation symptoms, and that Adasuve is administered only in a hospital setting. Also, short-acting beta-agonist bronchodilator treatment should be available for treatment of possible severe respiratory side-effects.
Alexza chief executive Thomas King noted that Adasuve is the first authorised non-injectable therapy for these indications, noting that it will be launched on both sides of the Atlantic in the third quarter - US approval was granted in December.
Spain's Ferrer has Adasuve rights in Europe, Latin America, Russia and the Commonwealth of Independent States countries. Chief executive Jordi Ramental said the focus for the initial EU launch will be Germany and Austria in 2013, adding that "at the same time, we are compiling the registration dossiers for the non-EU countries in our licensed territory".