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Rapid acute treatment of agitation in individuals with schizophrenia: multicentre, randomised, placebo-controlled study of inhaled loxapine

  • Michael D. Lesem (a1), Tram K. Tran-Johnson (a2), Robert A. Riesenberg (a3), David Feifel (a4), Michael H. Allen (a5), Robert Fishman (a6), Daniel A. Spyker (a6), John H. Kehne (a7) and James V. Cassella (a8)...

Abstract

Background

There is a need for a rapid-acting, non-injection, acute treatment for agitation.

Aims

To evaluate inhaled loxapine for acute treatment of agitation in schizophrenia.

Method

This phase III, randomised, double-blind, placebo-controlled, parallel-group study (ClinicalTrials.gov number NCT00628589) enrolled 344 individuals who received one, two or three doses of inhaled loxapine (5 or 10 mg) or a placebo. Lorazepam rescue was permitted after dose two. The primary efficacy end-point was change from baseline in Positive and Negative Syndrome Scale–Excited Component (PANSS–EC) 2 h after dose one. The key secondary end-point was Clinical Global Impression–Improvement scale (CGI–I) score 2 h after dose one.

Results

Inhaled loxapine (5 and 10 mg) significantly reduced agitation compared with placebo as assessed by primary and key secondary end-points. Reduced PANSS–EC score was evident 10 min after dose one with both 5 and 10mg doses. Inhaled loxapine was well tolerated, and the most common adverse events were known effects of loxapine or minor oral effects common with inhaled medications.

Conclusions

Inhaled loxapine provided a rapid, well-tolerated acute treatment for agitation in people with schizophrenia.

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Copyright

COPYRIGHT: © Royal College of Psychiatrists, 2011
This is an Open Access article, distributed under the terms of the Creative Commons Attribution-NonCommercial licence (http://creativecommons.org/licenses/by-nc/4.0/), which permits noncommercial re-use, distribution, and reproduction in any medium, provided the original work is unaltered and is properly cited. The written permission of Cambridge University Press must be obtained for commercial re-use or in order to create a derivative work.

Corresponding author

Michael D. Lesem, MD, Claghorn-Lesem Research Clinic Ltd, 1010 Waverly Street, Houston, Texas 77008, USA. Email: mlesem@claghorn-lesem.com

Footnotes

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∗

A portion of the data from this study was presented at the 2009 Annual Meeting of the American Psychiatric Association, San Francisco, USA.

The study was sponsored by Alexza Pharmaceuticals.

Declaration of interest

The study was sponsored by Alexza Pharmaceuticals. M.D.L., T.K.T-J, R.A.R. and D.F. were investigators. M.H.A., R.F., D.A.S., J.H.K. and J.V.C. were consultants to or employees of Alexza Pharmaceuticals during study design, execution and/or analysis.

Footnotes

References

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  • Cited by 84

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Rapid acute treatment of agitation in individuals with schizophrenia: multicentre, randomised, placebo-controlled study of inhaled loxapine

  • Michael D. Lesem (a1), Tram K. Tran-Johnson (a2), Robert A. Riesenberg (a3), David Feifel (a4), Michael H. Allen (a5), Robert Fishman (a6), Daniel A. Spyker (a6), John H. Kehne (a7) and James V. Cassella (a8)...

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