FDA Approves sNDA for Label Changes to ADASUVE

The FDA has approved the supplemental New Drug Application for label changes to ADASUVE (loxapine) inhalation powder. ADASUVE is the first orally inhaled medication for the acute treatment of agitation associated with bipolar I or schizophrenia in adult patients.

The approved label changes include the removal of the requirement for immediate onsite access to equipment and personnel trained to manage acute bronchospasm, including advanced airway management.

Instead, the updated label will now require certified health care settings to have immediate onsite access to supplies and personnel trained to manage acute bronchospasm, as well as access to emergency response services. Facilities must also have a short-acting bronchodilator, including a nebulizer and inhalation solution, in the event that bronchospasm needs to be treated.

Original FDA approval of ADASUVE was based on clinical trials of treating acute agitation demonstrating the efficacy of inhaled loxapine in patients with schizophrenia and patients with bipolar I disorder. The most common adverse effects associated with ADASUVE were abnormal taste, sedation, and throat irritation.

The drug was initially made commercially available in the United States in March 2014. Alexza reacquired the US commercial rights to ADASUVE in February 2016, and the most recent sNDA was filed in December 2015. This came after the company consulted the FDA on the Risk Evaluation Mitigation Strategy (REMS) of the drug, including the impact of certain requirements in the previous REMS.

The labeling changes consist of revisions to the Boxed Warning and Warning and Precautions sections of the Prescribing Information.