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FDA approves sNDA for Adasuve for agitation in schizophrenia, bipolar I disorder
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The FDA recently approved a supplemental New Drug Application for changes to the product label and Risk Evaluation Mitigation Strategy Program for Adasuve, an inhalation powder for acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.
Adasuve (loxapine, Alexza Pharmacueticals Inc.) contains 10 mg of loxapine and is administered through Staccato, a single-use handheld drug delivery technology from Alexza.
Loxapine was originally approved by the FDA based on findings from two clinical trials assessing acute agitation in schizophrenia or bipolar I disorder.
Two hours after inhalation, individuals with schizophrenia exhibited a 49% reduction in agitation and those with bipolar I disorder achieved a 53% reduction, compared with a 33% and 27% reduction in participants who received placebo, respectively.
Ten minutes after inhalation, individuals with schizophrenia exhibited a 19% reduction in agitation and those with bipolar I disorder exhibited a 23% reduction, compared with a 10% reduction in participants who received placebo.
The approved changes to the product label and related Risk Evaluation Mitigation Strategy (REMS) Program include removal of the requirement for immediate on-site access to equipment and personnel trained to manage acute bronchospasm, including advanced airway management.
The updated Adasuve label and REMS program require certified health care settings have immediate on-site access to supplies and personnel trained to manage acute bronchospasm and ready access to emergency response services.
Facilities are now required to have a short-acting bronchodilator, including a nebulizer and inhalation solution for immediate treatment of bronchospasm.
The labeling changes also include revised Boxed Warning and Warning and Precautions sections of Prescribing Information.