Agitation can be one of the more frightening side effects of schizophrenia. Patients may start out feeling tense or uneasy, then quickly progress to violent behavior that threatens both themselves and others. Onset of symptoms is unpredictable and severe. The most acute episodes of agitation are treated with oral antipsychotic drugs or injectable therapies, often in emergency settings. Oral antipsychotic drugs can take 30 minutes to work, and injections are invasive. There is a large, unmet clinical need for an agitation treatment that is both fast-acting and noninvasive.
Alexza Pharmaceuticals of Mountain View, Calif., is focused on the development of inhalation drugs for the treatment of central nervous system disorders. The company’s proprietary technology, the Staccato system, vaporizes a drug into a condensed aerosol form that allows for rapid drug delivery when inhaled. The drug is quickly absorbed into the bloodstream through the deep lung, reaching its highest concentration in the blood within two to five minutes. Alexza is also incorporating the Staccato system into treatments for cancer pain, migraines and insomnia.
In December, the company filed its first New Drug Application for AZ-004 (Staccato loxapine) to treat agitation in patients with schizophrenia or bipolar disorder. The NDA application included safety and efficacy data from over 1600 patients across 13 different studies. In two Phase III clinical trials, AZ-004 significantly reduced agitation compared to placebo. The company expects to have FDA approval for AZ-004 by the fourth quarter of 2010.
Thomas King, President and CEO of Alexza Pharmaceuticals, was one of the presenters at last month’s OneMedForum. In this video, King discusses why 2010 is going to be an eventful year for Alexza.