Coming soon to an ER near you…Nasal spray delivery of med for the emergency control of agitation in schizophrenic and bipolar patients:
Agitation can occur in many people suffering from major psychiatric disorders, including schizophrenia, which affects approximately 2.4 million adults in the United States, and bipolar disorder, which affects approximately 5.7 million adults in the United States. More than 90% of these people will experience agitation in their lifetime. Agitation generally escalates over a short period of time with patients initially feeling uncomfortable, tense and restless. As the agitation intensifies, their behavior appears more noticeable to others as they become threatening and potentially violent, especially if the agitation is not treated. Agitation episodes are currently most often treated with antipsychotics and / or benzodiazepines in oral or intramuscular injection preparations. However, there are no non-invasive therapies that work within 30 minutes to help agitated patients in need of treatment.
About ADASUVE (Staccato loxapine) and the Staccato System
ADASUVE is an anti-agitation product candidate that combines Alexza’s proprietary Staccato system with loxapine, an antipsychotic currently available in the U.S. as an oral formulation for the management of schizophrenia. The Staccato system is a hand-held, single-dose inhaler that delivers a medication comparable to intravenous administration, but with greater ease, patient comfort and convenience. Click here to see an animation of how the Staccato system works. In clinical studies, ADASUVE has shown an onset of effect in 10 minutes of dosing, which is the first time point measured in the Phase 3 clinical studies. The ADASUVE NDA contains efficacy and safety data from more than 1,600 patients and subjects who have been studied in thirteen different clinical trials.
Read the full article here: http://www.marketwatch.com/story/alexza-announces-adasuvetm-staccato-loxapine-pdufa-goal-date-of-february-4-2012-2011-08-19?reflink=MW_news_stmpb