The FDA has approved Alexza Pharmaceutical’s Adasuve loxapine inhalation powder for the treatment of agitation in patients with schizophrenia or bipolar I disorder. The Staccato loxapine inhaler will be available only under a Risk Evaluation and Mitigation Strategy (REMS) and is to be administered only in healthcare facilities enrolled in the Adasuve REMS program. Use of the product involves a risk of bronchospasm in asthma and COPD patients, the company says, and the REMS program is designed to mitigate that risk.
Alexza President and CEo Thomas B. King commented, “The approval of Adasuve is an important event in the treatment of agitation. Adasuve is the first approved non-injectable therapy for the acute treatment of agitation in adults with schizophrenia and bipolar I disorder. As noted in the consensus guidelines for Best Practices in the Evaluation and Treatment of Agitation, we believe that the ability to deliver medications rapidly and non-invasively will be important for patients and the professionals who care for them. This is a landmark day for Alexza and we are proud of our accomplishments in developing this unique product. We project that Adasuve will be available for commercial launch early in the third quarter of 2013.”
Earlier this month, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion regarding Alexza’s MAA for Staccato loxapine.
Read the Alexza press release.
