NEW YORK (Reuters Health) Feb 02 – Loxapine inhaled through a new device effectively controls agitation in patients with schizophrenia, according to findings published online in the January 25th Journal of Clinical Psychiatry.
“This is a very simple device,” Dr. Michael H. Allen from University of Colorado Depression Center, Aurora, Colorado told Reuters Health by email.
“If you can breathe, you can use it. At the more severe end of the agitation spectrum, all but the most hostile, agitated patients can use it and will prefer it to injection. We hope that it will lead to fewer episodes of restraint and seclusion by offering a rapid alternative to forcible treatment.”
Dr. Allen and colleagues assessed the efficacy and safety of a single dose of loxapine delivered as a thermally generated aerosol in 129 agitated patients with schizophrenia or schizoaffective disorder. The current episode of agitation had lasted about a week.
The 10-mg inhaled dose of loxapine provided significantly greater improvement in the primary endpoint (Positive and Negative Syndrome Scale-excited component, PANSS-EC) at 2 hours than did placebo, whereas there was only a trend toward greater improvement with the 5-mg inhaled dose.
The superiority of PANSS-EC scores in the 10-mg group emerged 20 minutes after dosing and the trend of superiority in the 5-mg group was apparent 45 minutes after inhalation.
Results were similar for secondary outcomes of Clinical Global Impressions-Improvement scale (CGI-I) and Behavioral Activity Rating Scale (BARS).
Moreover, both doses of inhaled loxapine significantly prolonged the time to administration of first rescue medication and significantly reduced the use of rescue medication.
Adverse events occurred in a similar percentage of patients in the 5-mg group (14/45, 31%), 10-mg group (16/41, 39%), and placebo group (14/43, 33%), with dysgeusia, sedation, and dizziness being most frequently reported. None of the patients withdrew from the study because of adverse events.
“We think one of the major pluses of this device is that it literally puts more control in the hands of consumers,” Dr. Allen said. “Staff show them how to use it rather than holding them down and forcing it on them. This is huge because many of our patients have been previously victimized and the symbolism of the injection method triggers traumatic memories. The Staccato device (Alexza Pharmaceuticals, Inc.) allows more of a partnership with the patient and a brief wait for results.”
“The company has focused on the delivery device, not the drugs per se, and their efforts are devoted to proofs of concept for other drugs in other disease states,” Dr. Allen said. “We just happened to have the most rapid success with the loxapine for agitation example of this model.”
Four of the 8 authors have served as consultants or speakers or have received grant/research support from Alexza, which funded the study. Two other authors are employees of and stock shareholders in Alexza.
By Will Boggs MD
Reuters Health Information