The US Food and Drug Administration (FDA) has approved loxapine ( Adasuve , Alexza Pharmaceuticals) inhalation powder 10 mg for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.
An estimated 3.2 million patients are currently receiving treatment for schizophrenia or bipolar I disorder in the United States. Of these, approximately 90% will develop agitation during the course of their illness.
Patients average 11 to 12 episodes of agitation each year.
Adasuve combines loxapine, an antipsychotic, with the company's propriety Staccato delivery system.
" Adasuve is the first approved noninjectable therapy for the acute treatment of agitation in adults with schizophrenia and bipolar disorder," Thomas King, president and CEO of Alexza Pharmaceuticals Inc, Mountain View, California, said in a release.
"[And] we believe that the ability to deliver medications rapidly and noninvasively will be important for patients and the professionals who care for them."
The FDA based its approval of loxapine inhalation powder on clinical data involving more than 1600 patients and control participants.
In 2 phase 3 trials — 1 in schizophrenia and 1 in bipolar 1 disorder — loxapine inhalation powder 10 mg met the primary efficacy endpoint, demonstrating statistically significant reductions in agitation compared with placebo 2 hours post dosing.
The drug also acted rapidly — statistically significant reductions in agitation were observed 10 minutes following the administration of active therapy.
Loxapine can cause bronchospasm that can lead to respiratory distress or arrest in patients with asthma or chronic obstructive pulmonary disease (COPD).
It also carries a warning that there is a risk for bronchospasm and increased mortality in elderly patients with dementia-related psychosis.
In recognition of its potential for serious adverse events, loxapine inhalation powder 10 mg will only be available through a restricted program under a risk evaluation and mitigation strategy known as the Adasuve REMS.
The drug can also only be administered in a healthcare facility that has immediate access to equipment and personnel trained to manage acute bronchospasm, including advanced airway management.
Loxapine inhalation powder 10 mg is not approved for the treatment of patients with dementia-related psychosis, and it is contraindicated in patients with a current diagnosis or history of asthma, COPD, or other lung diseases associated with bronchospasm.
It is also contraindicated in patients with acute respiratory signs or symptoms as well as in patients who are currently using medications to treat airways disease such as asthma or COPD.
Patients with a history of bronchospasm following treatment with the drug should also not receive loxapine inhalation powder 10 mg.
Adasuve is manufactured by Alexza Pharmaceuticals in Mountain View, California.