FDA grants approval for Alexza’s sNDA for Schizophrenia


The FDA has approved Alexza Pharmaceuticals supplemental new drug application (sNDA) which sought changes in the product label and modifications to the risk evaluation mitigation strategy (REMS) program for Adasuve inhalation powder, the only orally inhaled medicine available to treat agitation associated with schizophrenia or bipolar I disorder in adults.

Adasuve is administered through Alexza’s Staccato single-use, hand held drug delivery system.  Alexa’s system allows for rapid systemic delivery by inhalation of a thermally-generated aerosol of loxapine, an antipsychotic, to the lung.  Administration of Adasuve results in rapid absorption of loxapine, with a maximum plasma concentration achieved in approximately 2 minutes.

The original FDA approval of Adasuve was based on clinical efficacy of inhaled loxapine, demonstrated in two pivotal clinical trials of treating acute agitation: one in patients with schizophrenia and the other in patients with bipolar I disorder.

Patients receiving Adasuve experienced a significant reduction in agitation at two hours, the primary endpoint of the studies.  These studies demonstrated a 49% reduction in agitation symptoms from baseline in schizophrenia patients, as compared to 33% in patients receiving placebo; and a 53% reduction from baseline in bipolar I patients, as compared to 27% in patients receiving placebo.

In these two studies, reduction of agitation was rapidly achieved at 10 minutes post-dose, the first time point studied in the trials, with a 19% reduction in agitation from baseline in schizophrenia patients and a 23% reduction in bipolar I patients, both as compared to 10% in patients receiving placebo.


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