Alexza Pharmaceuticals Inc. (ALXA) announced Friday that the U.S. Food and Drug Administration approved Adasuve (loxapine) Inhalation Powder 10 mg for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.
Adasuve combines Alexza's proprietary Staccato delivery system with the antipsychotic drug, loxapine. The Staccato system is a hand-held inhaler that delivers a drug aerosol to the deep lung that results in rapid systemic delivery and absorption of a drug.
The company projects Adasuve will be available for commercial launch early in the third quarter of 2013.
As part of the Adasuve development program, Alexza identified a risk of bronchospasm in certain asthma and chronic obstructive pulmonary disease (COPD) patients following dosing with Adasuve. It is important to note that Adasuve can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest. Adasuve will be available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Adasuve REMS.
The company said that Adasuve should only be administered in a healthcare facility enrolled in the Adasuve REMS program that has immediate access on-site to equipment and personnel trained to manage acute bronchospasm, including advanced airway management (intubation and mechanical ventilation). In addition to product labeling, Alexza developed the Adasuve REMS with the purpose of mitigating the risk of bronchospasm.
The European Commission is now expected to grant marketing authorization for ADASUVE in all 27 European Union Member States, plus Iceland, Lichtenstein and Norway. A decision is expected from the European Commission in the first quarter of 2013.
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