Loxapine inhalation powder: A review of its use in the acute treatment of agitation in patients with bipolar disorder or schizophrenia

CNS Drugs

Volumn 27, Issue 6, 2013, Pages 479-489

  Keating, Gillian M ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

ADRENALIN; ANXIOLYTIC AGENT; BUTYROPHENONE; CIPROFLOXACIN; CLOZAPINE; CYTOCHROME P450 1A2; CYTOCHROME P450 2A6; CYTOCHROME P450 2B6; CYTOCHROME P450 2C19; CYTOCHROME P450 2C8; CYTOCHROME P450 2C9; CYTOCHROME P450 2D6; CYTOCHROME P450 2E1; CYTOCHROME P450 3A4; DOPAMINE 1 RECEPTOR; DOPAMINE 2 RECEPTOR; FLUVOXAMINE; HYPNOTIC AGENT; LOXAPINE; MEFLOQUINE; MUSCARINIC M1 RECEPTOR; MUSCLE RELAXANT AGENT; NEUROLEPTIC AGENT; OPIATE; PHENOTHIAZINE; PLACEBO; SEROTONIN UPTAKE INHIBITOR; TRAMADOL; TRICYCLIC ANTIDEPRESSANT AGENT; UNINDEXED DRUG;

ACUTE RESPIRATORY FAILURE; AGITATION; AKATHISIA; ANTICHOLINERGIC EFFECT; AREA UNDER THE CURVE; ARTICLE; BIPOLAR I DISORDER; BLOOD LEVEL; BRONCHOSPASM; CHRONIC LUNG DISEASE; CHRONIC OBSTRUCTIVE LUNG DISEASE; COUGHING; DRUG ABSORPTION; DRUG ACCUMULATION; DRUG DELIVERY SYSTEM; DRUG EFFICACY; DRUG EXCRETION; DRUG METABOLISM; DRUG RECEPTOR BINDING; DRUG SAFETY; DRUG STRUCTURE; DRUG TOLERABILITY; DYSGEUSIA; DYSPNEA; DYSTONIA; FAINTNESS; FORCED EXPIRATORY VOLUME; GASTROENTERITIS; HUMAN; HYPOTENSION; IN VITRO STUDY; IN VIVO STUDY; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY (TOPIC); NONHUMAN; OCULOGYRIC CRISIS; PHARMACODYNAMICS; PHARMACOKINETICS; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PLASMA CONCENTRATION-TIME CURVE; POSITIVE AND NEGATIVE SYNDROME SCALE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESPIRATION DEPRESSION; SCHIZOPHRENIA; SEDATION; SIDE EFFECT; SINGLE DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT CONTRAINDICATION; TREATMENT RESPONSE; WHEEZING;

ADMINISTRATION, INHALATION; ANTIPSYCHOTIC AGENTS; BIPOLAR DISORDER; DRUG DELIVERY SYSTEMS; DRY POWDER INHALERS; HUMANS; LOXAPINE; POWDERS; PSYCHOMOTOR AGITATION; SCHIZOPHRENIA;

EID: 84879291163     PISSN: 11727047     EISSN: 11791934     Source Type: Journal    
DOI: 10.1007/s40263-013-0075-9     Document Type: Article

References (47)

1. Sachs GS. A review of agitation in mental illness: burden of illness and underlying pathology. J Clin Psychiatry. 2006;67(Suppl. 10):5-12.
2. Caine ED. Clinical perspectives on atypical antipsychotics for treatment of agitation. J Clin Psychiatry. 2006;67(Suppl 10):22-31.
3. Allen MH, Currier GW, Carpenter D, et al. The expert consensus guideline series: treatment of behavioral emergencies 2005. J Psychiatr Pract. 2005;11(Suppl. 1):5-108.
4. Wilson MP, Pepper D, Currier GW, et al. The psychopharmacology of agitation: consensus statement of the American Association for Emergency Psychiatry project BETA psychopharmacology workgroup. West J Emerg Med. 2012;13(1):26-34.
5. Lukens TW, Wolf SJ, Edlow JA, et al. Clinical policy: critical issues in the diagnosis and management of the adult psychiatric patient in the emergency department. Ann Emerg Med. 2006;47(1):79-99.
6. Marder SR. A review of agitation in mental illness: treatment guidelines and current therapies. J Clin Psychiatry. 2006;67(Suppl. 10):13-21.
7. Nordstrom K. Inhaled loxapine for rapid treatment of agitation in schizophrenia and bipolar disorder: an update. Neuropsychiatry. 2012;2(3):253-60.
8. Chakrabarti A, Bagnall AM, Chue P, et al. Loxapine for schizophrenia. Cochrane Database Syst Rev. 2007(4):CD001943.
9. Alexza Pharmaceuticals Inc. Adasuve™ (loxapine) inhalation powder, for oral inhalation use: US prescribing information; 2012. http://www.adasuve. com/ (Accessed 9 May 2013).
10. European Medicines Agency. Adasuve (loxapine) inhalation powder: EU summary of product characteristics; 2013. http://ec.europa.eu/health/documents/ community-register/2013/20130220125343/anx-125343-en.pdf (Accessed 9 May 2013).
11. Lesem MD, Tran-Johnson TK, Riesenberg RA, et al. Rapid acute treatment of agitation in individuals with schizophrenia: multicentre, randomised, placebo-controlled study of inhaled loxapine. Br J Psychiatry. 2011;198(1):51-8.
12. Cassella J, Spyker D, Kwentus J, et al. Rapid improvement in the five-item PANSS-EC scale for agitation with inhaled loxapine (AZ-004) [poster]. New Clinical Drug Evaluation Unit 2010 Meeting; 14-17 Jun 2010; Boca Raton (FL).
13. Alexza Pharmaceuticals. Adasuve (loxapine) inhalation powder NDA 022549: Psychopharmacologic Drug Advisory Committee briefing document. 2011. http://google2.fda.gov/search?q=cache:JPZyU1bYqqYJ:www.fda.gov/downloads/ AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ PsychopharmacologicDrugsAdvisoryCommittee/UCM282900.pdf+Adasuve+(loxapine) +inhalation+powder+NDA+022549&client=FDAgov&site=FDAgov&lr= &proxystylesheet=FDAgov&output=xml-no-dtd&ie=UTF-8&access= p&oe=UTF-8 (Accessed 8 May 2013).
14. ® loxapine. Int J Pharm. 2011;403(1-2):101-8.
15. Gao Q, Lew A, Takahashi LH, et al. An investigation into the morphology of loxapine in a thermal aerosolization process from crystalline to amorphous. J Pharm Sci. 2011;100(4):1407-15.
16. ® loxapine. J Aerosol Med Pulm Drug Deliv. 2010;23(4):253-60.
17. Li Z, Ichikawa J, Meltzer HY. A comparison of the effects of loxapine with ziprasidone and thioridazine on the release of dopamine and acetylcholine in the prefrontal cortex and nucleus accumbens. Psychopharmacology (Berl). 2003;167(3):315-23.
18. Singh AN, Barlas C, Saeedi H, et al. Effect of loxapine on peripheral dopamine-like and serotonin receptors in patients with schizophrenia. J Psychiatry Neurosci. 2003;28(1):39-47.
19. 2 blockade in determining atypicality. Schizophr Res. 2005;77(2-3):189-99.
20. 3H-Spiroperidol binding to dopamine receptors in rat striatal membranes: influence of loxapine and its hydroxylated metabolites. Eur J Pharmacol. 1979;55(2):215-8.
21. 2 receptor subtypes. J Psychiatry Neurosci. 1996;21(1):29-35.
22. Glazer WM. Does loxapine have 'atypical' properties? Clinical evidence. J Clin Psychiatry. 1999;60(Suppl. 10):42-6.
23. 2 affinities differentiate atypical and typical antipsychotic drugs. Psychopharmacol Bull. 1989;25(3):390-2.
24. 2 receptors. Psychopharmacology (Berl). 1993;112(1 Suppl.):S40-54.
25. 2 receptors. J Pharmacol Exp Ther. 1993;266(3):1374-84.
26. 2 receptors: implications for the therapeutics of schizophrenia. Am J Psychiatry. 1997;154(11):1525-9.
27. Spyker DA, Gottwald MD, Fishman RS. The cardiovascular safety of inhaled loxapine (AZ-004) [abstract no. NR6-6 plus poster]. 163rd Annual Meeting of the American Psychiatric Association; 22-27 May 2010; New Orleans (LA).
28. US Food and Drug Administration. Clinical review: NDA 22549 SD-28; 2011. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM282897.pdf (Accessed 8 May 2013).
29. Kwentus J, Riesenberg RA, Marandi M, 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(1):31-40.
30. Spyker DA, Munzar P, Cassella JV. Pharmacokinetics of loxapine following inhalation of a thermally generated aerosol in healthy volunteers. J Clin Pharmacol. 2010;50(2):169-79.
31. Luo JP, Vashishtha SC, Hawes EM, et al. In vitro identification of the human cytochrome p450 enzymes involved in the oxidative metabolism of loxapine. Biopharm Drug Dispos. 2011;32(7):398-407.
32. Reed A, Huie K, Perloff ES, et al. Loxapine p-glycoprotein interactions in vitro. Drug Metab Lett. 2012;6(1):26-32.
33. Allen MH, Feifel D, Lesem MD, et al. Efficacy and safety of loxapine for inhalation in the treatment of agitation in patients with schizophrenia: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2011;72(10):1313-21.
34. Cassella J, Fishman R. Treating agitation with inhaled loxapine (AZ-004): efficacy analyses in patients with schizophrenia or bipolar disorder [poster]. 24th Annual US Psychiatry and Mental Health Congress; 7-10 Nov 2011; Las Vegas (NV).
35. Howland RH. Now take a deep breath: inhaled loxapine for the treatment of acute agitation. J Psychosoc Nurs Ment Health Serv. 2012;50(1):16-8.
36. ® (aripiprazole): US prescribing information; 2012. http://www.accessdata.fda.gov/drugsatfda-docs/ label/2012/021436s034,021713s025,021729s018,021866s020lbl.pdf (Accessed 9 May 2013).
37. Tran-Johnson TK, Sack DA, Marcus RN, et al. Efficacy and safety of intramuscular aripiprazole in patients with acute agitation: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2007;68(1):111-9.
38. Wright P, Birkett M, David SR, et al. Double-blind, placebo-controlled comparison of intramuscular olanzapine and intramuscular haloperidol in the treatment of acute agitation in schizophrenia. Am J Psychiatry. 2001;158(7):1149-51.
39. Meehan K, Zhang F, David S, et al. A double-blind, randomized comparison of the efficacy and safety of intramuscular injections of olanzapine, lorazepam, or placebo in treating acutely agitated patients diagnosed with bipolar mania. J Clin Psychopharmacol. 2001;21(4):389-97.
40. European Medicines Agency. Abilify (aripiprazole): EU summary of product characteristics; 2013. http://www.emea.europa.eu/docs/en-GB/document-library/ EPAR-Product-Information/human/000471/WC500020170.pdf (Accessed 9 May 2013).
41. Eli Lilly. Zyprexa (olanzapine): US prescribing information; 2010. http://www.accessdata.fda.gov/drugsatfda-docs/label/2010/020592s057,021086s036, 021253s045lbl.pdf (Accessed 9 May 2013).
42. European Medicines Agency. Zyprexa (olanzapine): EU summary of product characteristics; 2012. http://www.emea.europa.eu/docs/en-GB/document-library/ EPAR-Product-Information/human/000115/WC500055207.pdf (Accessed 9 May 2013).
43. Pfizer. Geodon (ziprasidone): US prescribing information; 2010. http://www.accessdata.fda.gov/drugsatfda-docs/label/2010/020825s038,020919s025, 021483s005lbl.pdf (Accessed 9 May 2013).
44. European Medicines Agency. Syncrest (asenapine) sublingual tablets: EU summary of product characteristics; 2013. http://www.emea.europa.eu/docs/en-GB/ document-library/EPAR-Product-Information/human/001177/WC500096895.pdf (Accessed 9 May 2013).
45. ® (asenapine) sublingual tablets: US prescribing information; 2012. http://www.accessdata.fda.gov/drugsatfda-docs/ label/2012/022117s013lbl.pdf (Accessed 9 May 2013).
46. Citrome L. Aerosolised antipsychotic assuages agitation: inhaled loxapine for agitation associated with schizophrenia or bipolar disorder. Int J Clin Pract. 2011;65(3):330-40.
47. American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 4th ed. Washington, DC: American Psychiatric Association; 1994.