Skip to main content
×
×
Home

Response to inhaled loxapine in patients with schizophrenia or bipolar I disorder: PANSS-EC responder analyses

  • Scott Zeller (a1), Leslie Zun (a2), James V. Cassella (a3), Daniel A. Spyker (a3) and Paul P. Yeung (a4)...
Abstract
Background

Efficacy of inhaled loxapine 5 or 10 mg in treating agitation was shown using the Positive and Negative Syndrome Scale – Excited Component (PANSS-EC) in two Phase III randomised, double-blind, placebo-controlled trials in 344 agitated patients with schizophrenia and 314 patients with bipolar I disorder (Clinicaltrials.gov: NCT00628589, NCT00721955).

Aims

To examine the five individual items comprising the PANSS-EC and the percentage of patients achieving a clinical response (reduction of ≥40%) in PANSS-EC (Response-40) for these two studies.

Method

Response-40 was examined at the primary end-point (2 h) and over time.

Results

Response-40 and each PANSS-EC item score were statistically significant v. placebo at 2 h and at each assessment time point for both doses.

Conclusions

Inhaled loxapine produced rapid improvement in agitated patients with schizophrenia or bipolar I disorder, achieving Response-40 at the first assessment (10 min post dose). These results highlight the effectiveness of loxapine across all components of agitation as measured by the PANSS-EC.

    • Send article to Kindle

      To send this article to your Kindle, first ensure no-reply@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about sending to your Kindle. Find out more about sending to your Kindle.

      Note you can select to send to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be sent to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

      Find out more about the Kindle Personal Document Service.

      Response to inhaled loxapine in patients with schizophrenia or bipolar I disorder: PANSS-EC responder analyses
      Available formats
      ×
      Send article to Dropbox

      To send this article to your Dropbox account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your <service> account. Find out more about sending content to Dropbox.

      Response to inhaled loxapine in patients with schizophrenia or bipolar I disorder: PANSS-EC responder analyses
      Available formats
      ×
      Send article to Google Drive

      To send this article to your Google Drive account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your <service> account. Find out more about sending content to Google Drive.

      Response to inhaled loxapine in patients with schizophrenia or bipolar I disorder: PANSS-EC responder analyses
      Available formats
      ×
Copyright
This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Corresponding author
Daniel A. Spyker, Alexza Pharmaceuticals, 2091 Stierlin Ct, Mountain View, CA 94043, USA. Email: dspyker@alexza.com
Footnotes
Hide All

Declaration of interest

S.Z. is a member of the speakers bureau for Grupo Ferrer. L.Z. has been a speaker and grant recipient for Teva Pharmaceuticals. J.V.C. and D.A.S. were employees of Alexza Pharmaceuticals during execution of the studies, and are currently paid consultants for and have received stock and/or stock options from Alexza Pharmaceuticals. P.P.Y. is a full-time employee and receives stock options from Teva Pharmaceuticals.

Footnotes
References
Hide All
1 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). APA, 2013.
2 Alderfer, BS, Allen, MH. Treatment of agitation in bipolar disorder across the life cycle. J Clin Psychiatry 2003; 64 (suppl 4): 39.
3 Hankin, CS, Bronstone, A, Koran, LM. Agitation in the inpatient psychiatric setting: a review of clinical presentation, burden, and treatment. J Psychiatr Pract 2011; 17: 170–85.
4 Marder, SR. A review of agitation in mental illness: treatment guidelines and current therapies. J Clin Psychiatry 2006; 67 (suppl 10): 1321.
5 Nordstrom, K, Allen, MH. Alternative delivery systems for agents to treat acute agitation: progress to date. Drugs 2013; 73: 1783–92.
6 Bourdinaud, V, Pochard, F. Survey of management methods for patients in a state of agitation at admission and emergency departments in France [in French]. Encephale 2003; 29: 8998.
7 Adasuve [prescribing information]. Alexza Pharmaceuticals, 2013.
8 European Medicines Agency. Adasuve (loxapine) Inhalation Powder: EU Summary of Product Characteristics. (http://ec.europa.eu/health/documents/community-register/2013/20130220125343/anx_125343_en.pdf).
9 Lesem, MD, Tran-Johnson, TK, Riesenberg, RA, Feifel, D, Allen, MH, Fishman, R, et al. Rapid acute treatment of agitation in individuals with schizophrenia: multicentre, randomised, placebo-controlled study of inhaled loxapine. Br J Psychiatry 2011; 198: 51–8.
10 Kwentus, J, Riesenberg, RA, Marandi, M, Manning, RA, Allen, MH, Fishman, RS, et al. Rapid acute treatment of agitation in patients with bipolar I disorder: a multicenter, randomized, placebo-controlled clinical trial with inhaled loxapine. Bipolar Disord 2012; 14: 3140.
11 Citrome, L. Inhaled loxapine for agitation revisited: focus on effect sizes from 2 Phase III randomised controlled trials in persons with schizophrenia or bipolar disorder. Int J Clin Pract 2012; 66: 318–25.
12 Montoya, A, Valladares, A, Lizan, L, San, L, Escobar, R, Paz, S. Validation of the Excited Component of the Positive and Negative Syndrome Scale (PANSS-EC) in a naturalistic sample of 278 patients with acute psychosis and agitation in a psychiatric emergency room. Health Qual Life Outcomes 2011; 9: 18.
13 Emsley, R, Rabinowitz, J, Torreman, M. The factor structure for the Positive and Negative Syndrome Scale (PANSS) in recent-onset psychosis. Schizophr Res 2003; 61: 4757.
14 Leucht, S, Kane, JM, Kissling, W, Hamann, J, Etschel, E, Engel, RR. What does the PANSS mean? Schizophr Res 2005; 79: 231–8.
15 Pratts, M, Citrome, L, Grant, W, Leso, L, Opler, LA. A single-dose, randomized, double-blind, placebo-controlled trial of sublingual asenapine for acute agitation. Acta Psychiatr Scand 2014; 130: 61–8.
16 Citrome, L. Comparison of intramuscular ziprasidone, olanzapine, or aripiprazole for agitation: a quantitative review of efficacy and safety. J Clin Psychiatry 2007; 68: 1876–85.
17 Cassella, J, Fishman, R, Spyker, D. Inhaled loxapine rapidly improves acute agitation in schizophrenic patients. Presented at: American Psychiatric Association 162nd Annual Meeting, 16–21 May 2009, San Francisco, California, USA. Available at: http://www.europeanneuropsychopharmacology.com/article/S0924-977X(10)70765-3/abstract.
18 Spyker, DA, Munzar, P, Cassella, JV. Pharmacokinetics of loxapine following inhalation of a thermally generated aerosol in healthy volunteers. J Clin Pharmacol 2010; 50: 169–79.
19 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR). APA, 2000.
20 Kay, SR, Fiszbein, A, Opler, LA. The Positive and Negative Syndrome Scale (PANSS) for schizophrenia. Schizophr Bull 1987; 13: 261–76.
21 Kay, SR. Significance of the positive-negative distinction in schizophrenia. Schizophr Bull 1990; 16: 635–52.
22 Dinh, K, Myers, DJ, Noymer, PD, Cassella, JV. In vitro aerosol characterisation of Staccato® Loxapine. Int J Pharm 2011; 403: 101–8.
Recommend this journal

Email your librarian or administrator to recommend adding this journal to your organisation's collection.

BJPsych Open
  • ISSN: -
  • EISSN: 2056-4724
  • URL: /core/journals/bjpsych-open
Please enter your name
Please enter a valid email address
Who would you like to send this to? *
×

Metrics

Altmetric attention score

Full text views

Total number of HTML views: 0
Total number of PDF views: 51 *
Loading metrics...

Abstract views

Total abstract views: 129 *
Loading metrics...

* Views captured on Cambridge Core between 2nd January 2018 - 26th May 2018. This data will be updated every 24 hours.

Response to inhaled loxapine in patients with schizophrenia or bipolar I disorder: PANSS-EC responder analyses

  • Scott Zeller (a1), Leslie Zun (a2), James V. Cassella (a3), Daniel A. Spyker (a3) and Paul P. Yeung (a4)...
Submit a response

eLetters

No eLetters have been published for this article.

×

Reply to: Submit a response


Your details


Conflicting interests

Do you have any conflicting interests? *