First orally inhaled drug available for agitation in schizophrenia, bipolar disorder

Teva Pharmaceutical Industries launched loxapine inhalation powder, 10 mg (Adasuve) March 3, for the acute treatment of agitation associated with schizophrenia or bipolar 1 disorder in adults.

The company said that it is the first and only orally inhaled medicine for this treatment and is administered using the Staccato single-use, hand-held drug delivery device (Alexza Pharmaceutical). Patients will receive the maximum plasma concentration of loxapine within two minutes after administration.

“Existing treatment options for patients with agitation associated with schizophrenia or bipolar 1 disorder are limited to oral tablets or injectable modes of administration, sometimes requiring the use of restraints,” said Richard Jaffee, MD, medical director for Research and Clinical Trials at the Belmont Center for Comprehensive Treatment, Philadelphia, Penn., and a clinical trial investigator. “Adasuve is a drug-device combination that offers healthcare providers a new option to help manage agitation.”

Approximately 7 million agitation episodes associated with schizophrenia and bipolar disorder result in an acute emergency treatment setting each year, leading to behaviors that can interfere with patient care, including threatening behaviors, escalating or distressing behavior or self-exhausting behaviors.

“The availability of orally inhaled Adasuve provides a rapid onset of action that quickly improves symptoms for patients and gives providers in enrolled hospitals another treatment choice,” said Michael McHugh, vice president and general manager, Teva Select Brands and Teva Women’s Health.

Adasuve was approved with safety information, including boxed warnings and a Risk Evaluation and Mitigation Strategy (REMS) program. The drug-device combination can only be administered in an enrolled healthcare facility with trained personnel to manage acute bronchospasm, including advanced airway management. Bronchospasm has the potential to lead to respiratory distress and respiratory arrest, according to the boxed warning.

Adasuve is contraindicated in patients with a diagnosis or history of asthma, chronic obstructive pulmonary disorder (COPD), or other lung disease associated with bronchospasm. It also should not be used in patients with acute respiratory signs/symptoms, such as wheezing, and patients who are using medications to treat asthma or COPD. It is also not approved for elderly patients with dementia-related psychosis.

For more information, consult the safety information in the package insert.