Adasuve (loxapine) Inhalation Powder was approved late last week by the U.S. Food and Drug Administration (FDA) for the treatment of agitation in bipolar I disorder and schizophrenia in adults.
Adasuve combines a proprietary delivery system with the antipsychotic drug, loxapine. The Staccato delivery system is a hand-held inhaler that delivers a drug aerosol to the deep lung that results in rapid systemic delivery and absorption of a drug, similar to an asthma inhaler. Adasuve is manufactured by Alexza Pharmaceuticals.
Adasuve (loxapine) Inhalation Powder comes in a 10 mg form.
Agitation, according to the company’s news release, is a serious problem that can present in a number of psychiatric disorders, including schizophrenia and bipolar I disorder. Of the estimated 3.2 million patients treated for schizophrenia or bipolar I disorder in the U.S., about 90 percent suffer from some type of agitation in their lifetime. The agitation can be due to the natural course of underlying disease or because of non-compliance with chronic medication. Most patients average 11 to 12 episodes of agitation each year.
Agitation episodes may escalate unpredictably and, in some cases, necessitate chemical or physical restraint to relieve the individual’s distress and to protect care providers and others in close proximity. Rapid, effective and safe intervention is key to returning the agitated person to a less agitated state.
In two phase III trials (one each in bipolar disorder and schizophrenia), loxapine inhalation powder 10 mg demonstrated statistically significant reductions in agitation compared with placebo, 2 hours after patients received a dose. The studies involved more than 1,600 subjects.
The drug also acted rapidly with statistically significant reductions in agitation observed 10 minutes following the administration of active therapy.
“Adasuve is the first approved non-injectable therapy for the acute treatment of agitation in adults with schizophrenia and bipolar I disorder,” said Thomas B. King, President and CEO of Alexza Pharmaceuticals.
“…[W]e believe that the ability to deliver medications rapidly and non-invasively will be important for patients and the professionals who care for them.”
“The data we have seen from the Adasuve Phase 3 clinical trials in patients with schizophrenia and bipolar I disorder are compelling,” said Michael Lesem, MD, Executive Medical Director, Claghorn-Lesem Research Clinic, Houston, TX and a principal investigator in the Adasuve clinical trials.
“I believe that Adasuve represents an important new and much needed therapeutic option in treating agitation patients who will benefit from a non-coercive therapeutic intervention that works quickly to relieve their symptoms.”
As part of the Adasuve development program, Alexza identified a risk of bronchospasm in certain asthma and chronic obstructive pulmonary disease (COPD) patients following dosing with Adasuve.
It is important to note that Adasuve can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest. Adasuve will be available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Adasuve REMS (described below).
Source: FDA and news release