Acute agitation is one of the most severe symptoms of disorders for such conditions as schizophrenia and bipolar, and includes tension, hostility and irritability. These psychiatric disorders are fairly common, with around 2.4 million people in the U.S. affected by schizophrenia and 5.7 million by bipolar disease. It's predicted that around 9 in every 10 of people with these disorders experience agitation at least once.
The treatment uses the Staccato delivery system developed by Alexza Pharmaceuticals, Inc. to release the antipsychotic drug Ioxapine into the lungs, which is then quickly absorbed by the body. As the first non-injectable form of therapy for relieving symptoms of agitation, ADUSAVE represents a non-coercive treatment that will quickly lessen the symptoms of many patients with agitation.
Thomas B. King, President and CEO of Alexza, said:
"The approval of ADASUVE is an important event in the treatment of agitation. ADASUVE is the first approved non-injectable therapy for the acute treatment of agitation in adults with schizophrenia and bipolar I disorder. As noted in the consensus guidelines for Best Practices in the Evaluation and Treatment of Agitation, we believe that the ability to deliver medications rapidly and non-invasively will be important for patients and the professionals who care for them. This is a landmark day for Alexza and we are proud of our accomplishments in developing this unique product. "
The approval decision made by the FDA was based on results of the performance of the drug in clinical trials. Two Phase 3 clinical trials were carried out which included a total of 1,600 patients taking either ADASUVE or placebo. The first Phase 3 clinical trial focused solely on schizophrenic patients while the second trial focused on bipolar patients. They found that a 10mg dose of ADASUVE was found to be statistically much better at reducing symptoms of agitation compared to placebo, with symptoms of agitation dropping drastically after only 10 minutes of taking the 10mg ADUSAVE dose.
According to a principal investigator in the ADASUVE clinical trials, Michael Lesem, MD, Executive Medical Director, Claghorn-Lesem Research Clinic, Houston, TX:
"The data we have seen from the ADASUVE Phase 3 clinical trials in patients with schizophrenia and bipolar I disorder are compelling. 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."
It should be noted that patients with asthma and chronic obstructive pulmonary disease (COPD) who took ADASUVE were found to be at a higher risk of bronchospasm. The condition causes severe problems with breathing and can eventually result in respiratory arrest or respiratory diseases. For this reason the drug's administration will be monitored by the ADASUVE Risk Evaluation and Mitigation Strategy (ADASUVE REMS).
Written by Joseph Nordqvist