Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today announced that ADASUVE® inhalation powder, pre-dispensed (loxapine) is now available in Guatemala. This approval represents the first ADASUVE approval in Latin America for Ferrer and Alexza. Ferrer is Alexza's commercial partner for ADASUVE in the EU, Latin America and Commonwealth of Independent States countries.
Ferrer introduced ADASUVE during a psychiatric medical meeting in Guatemala, hosted by Congreso National de Psiquiatria de Guatemala, held in Guatemala City, August 7 - 8, 2014. During the meeting, Ferrer hosted a symposium on agitation, entitled "ADASUVE: una innovacion terapeutica en el tratamiento de la agitacion" or "ADASUVE: A therapeutic innovation in the treatment of agitation."
"Ferrer is making strong progress in securing approvals for ADASUVE," said Thomas B. King, President and CEO of Alexza. "We are pleased with their progress, as the Guatemala approval represents Ferrer's first non-EU submission and approval of ADASUVE."
"Launching ADASUVE in the first Latin American country is an important milestone in our collaboration with Alexza and our commercial plan for ADASUVE," said Antoni Villaro, Chief Operating Officer of Ferrer. "We believe ADASUVE provides an important new option for clinicians who treat patients with agitation associated with schizophrenia or bipolar disorder."
ADASUVE is the first and only inhalation therapy for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. The marketing authorization for ADASUVE requires that patients receive regular treatment immediately after administration of the product to control acute agitation symptoms. It also requires that ADASUVE 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.
Ferrer estimates that approximately 10 million adults in Latin America suffer from schizophrenia or bipolar disorder1. Agitation is a common symptom for these patients2, characterized by feelings of distress, anxiety, and loss of control.
Alexza Pharmaceuticals, Inc. and Ferrer are parties to the collaboration agreement for ADASUVE pursuant to which Alexza, as the exclusive supplier of ADASUVE, is responsible for all aspects of manufacture of the product. Ferrer is expected to launch ADASUVE in additional EU and Latin American countries in 2014 and 2015.
Alexza Pharmaceuticals, Inc.