The European Commission has approved Alexza’s inhaled antipsychotic Adasuve in the EU for the rapid control of mild-to-moderate agitation in adults with schizophrenia or bipolar disorder.
The decision is a major boost for California-based Alexza, and follows approval in the US late last year for what is the company’s lead product.
Alexza has partnered with Spanish pharma company Grupo Ferrer to market the drug in Europe, Latin America, Russia and the Commonwealth of Independent States, and the two will work together to prepare for the European launch of Adasuve in the third quarter of 2013. This will coincide with the US launch, which will be handled solely by Alexza.
Jordi Ramentol, CEO of Grupo Ferrer, confirmed that Germany and Austria will be the focus of the drug’s European launch, with other EU nations to follow in 2014.
“At the same time, we are compiling the registration dossiers for the non-EU countries in our licensed territory, and we plan to complete all of these submissions before the end of 2013,” he added.
Adasuve is developed as a more patient-friendly alternative to injectable antipsychotics, with patients able to administer the drug using a hand-held inhaler.
“We believe that the ability to deliver this medicinal product rapidly and non-invasively will be important for patient care,” said Thomas King, president and CEO of Alexza.
However, the European approval only covers the use of Adasuve in a hospital setting under the supervision of a healthcare professional who has access to a short-acting beta-agonist bronchodilator. This is due to the possibility of severe respiratory side effects, and is based on a recommendation by European Medicines Agency committee.
In clinical trials, Adasuve demonstrated decreased agitation 10 minutes after the first dose, with the drug working by stimulating dopamine D2 receptors and serotonin 5-HT2A receptors to suppress aggressive behaviour.