The Role of Inhaled Loxapine in the Treatment of Acute Agitation in Patients with Psychiatric Disorders: A Clinical Review
Abstract
:1. Introduction
2. Overview of Inhaled Loxapine
2.1. Mechanism of Action
2.2. Inhaled Loxapine: The Staccato® System Delivery
2.3. Studies on Healthy Subjects and Pharmacokinetics of Inhaled Loxapine
2.4. Clinical Trials of Inhaled Loxapine in the Treatment of Agitation in Psychiatric Disorders
2.5. Common Adverse Effects of Inhaled Loxapine in Patients with Psychiatric Disorders
2.6. Pulmonary AEs of Inhaled Loxapine
3. A Clinical Perspective on the Role of Inhaled Loxapine in the Anti-Agitation Drugs Armamentarium: Pros and Cons
4. Conclusions
Acknowledgments
Author Contributions
Conflicts of Interest
References
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Route of Administration | Inhalatory |
---|---|
Half Life | 6–8 h |
Time to peak concentration | 2 min |
Preparation instructions | Inhalation powder. 10 mg unit in a single-use inhaler |
Food and Drug Administration (FDA) Indications | Acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults |
Available Dosage | 10 mg |
Maximum Dosage | 10 mg/24 h |
Average dose for tranquillization | 10 mg/24 h |
Recommendations | Administration requires a somewhat, partial or fully cooperative patient. Contraindicated in patients with diagnosis or history of asthma, Chronic Obstructive Pulmonary Disease (COPD), other lung disease associated with bronchospasm or in patients with acute respiratory symptoms or signs and with current use of medications to treat airways disease. It is not approved for the treatment of patients with dementia-related psychosis |
Costs | $174/dose in USA (EUR price not yet available) |
Authors | Year | Study Sample | Study Design | Number of Subject | Study Aims | Dose (mg/Day) | Main Findings |
---|---|---|---|---|---|---|---|
Spyker et al. | 2010 | Healthy subjects | Randomized, double-blind, placebo-controlled, dose escalation study | 50 | To determine the pharmacokinetic characteristics, safety, and tolerability of single doses of inhaled loxapine | 0.625, 1.25, 2.5, 5.0, or 10 mg of loxapine or placebo | The inhalation of loxapine represented a safe and well-tolerated route for rapidly achieving therapeutic plasma concentrations |
Spyker et al. | 2014 | Healthy subjects | randomized, placebo-controlled, double-blind crossover study | 48 | To evaluate effects of inhaled loxapine on the QTc interval | Inhaled loxapine 10 mg or inhaled placebo | No QTc prolongation was observed with the therapeutic dose of inhaled loxapine |
Cassella et al. | 2015 | Healthy subjects | randomized, double-blind, active- and placebo-controlled, crossover, thorough QT study | 60 | To assessed the effect of two inhaled loxapine doses on cardiac repolarization as measured by QTc interval | inhaled loxapine (10 mg) 2 h apart+oral placebo, two doses of inhaled placebo+oral placebo, or two doses of inhaled placebo+oralmoxifloxacin (400 mg; positive control) | The two therapeutic doses of inhaled loxapine did not cause threshold QTc prolongation |
Spyker et al. | 2015 | Healthy subjects | Randomized, double-blind, crossover study | 22 | Pharmacodynamic effects and safety of single-dose inhaled loxapine and IM lorazepam in combination versus each agent alone | lorazepam 1 mg IM, inhaled loxapine 10 mg, placebo IM (alone or combined) | Concomitant administration of inhaled loxapine and lorazepam in healthy volunteers showed no difference in its effect on respiration rate or pulse oximetry (primary endpoints) versus either drug alone |
Authors | Year | Study Sample | Study Design | Number of Subject | Study Aims | Dose (mg/Day) | Main Findings |
---|---|---|---|---|---|---|---|
Allen et al. | 2011 | Agitated patients with schizophrenia | Phase II, randomized, double-blind, placebo-controlled study | 129 | To evaluate inhaled loxapine for acute treatment of agitation in schizophrenia | Single inhalation of 5 or 10 mg of loxapine or placebo | Inhaled loxapine was generally safe and well tolerated and produced rapid improvement in agitated patients with psychotic disorders |
Lesem et al. | 2011 | Agitated patients with schizophrenia | Phase III, randomised, double-blind, placebo-controlled, parallel-group study | 344 | To evaluate inhaled loxapine for acute treatment of agitation in schizophrenia | Two or three doses of inhaled loxapine (5 or 10 mg) or placebo | Inhaled loxapine was a well-tolerated and effective treatment of agitation in schizophrenia |
Kwentus et al. | 2012 | Agitated patients with bipolar I disorder | Phase III, randomized, double blind, placebo-controlled, parallel group inpatient study | 314 | To evaluate inhaled loxapine for the acute treatment of agitation in patients with bipolar I disorder | Inhaled loxapine 5 mg or 10 mg or inhaled placebo | Inhaled loxapine provided a rapid, non-injection, well-tolerated acute treatment for agitation in patients with bipolar I disorder |
Krüger et al. | 2015 | Agitated patients with borderline personality disorder | Case series | 5 | To evaluate inhaled loxapine for emergency treatment of agitated patients with borderline personality disorder | Inhaled loxapine 10 mg | Inhaled loxapine was safe, well tolerated and produced rapid improvement in agitated patients with borderline personality disorder |
Roncero et al. | 2016 | Patients with dual diagnosis | Retrospective case Series | 14 | Efficacy of inhaled loxapine on episodes of psychotic agitation in patients with dual diagnosis | Inhaled loxapine 10 mg | Inhaled loxapine was rapid, effective, and well accepted in all dual-diagnosis patients presenting with acute agitation in the emergency setting |
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De Berardis, D.; Fornaro, M.; Orsolini, L.; Iasevoli, F.; Tomasetti, C.; De Bartolomeis, A.; Serroni, N.; Valchera, A.; Carano, A.; Vellante, F.; et al. The Role of Inhaled Loxapine in the Treatment of Acute Agitation in Patients with Psychiatric Disorders: A Clinical Review. Int. J. Mol. Sci. 2017, 18, 349. https://doi.org/10.3390/ijms18020349
De Berardis D, Fornaro M, Orsolini L, Iasevoli F, Tomasetti C, De Bartolomeis A, Serroni N, Valchera A, Carano A, Vellante F, et al. The Role of Inhaled Loxapine in the Treatment of Acute Agitation in Patients with Psychiatric Disorders: A Clinical Review. International Journal of Molecular Sciences. 2017; 18(2):349. https://doi.org/10.3390/ijms18020349
Chicago/Turabian StyleDe Berardis, Domenico, Michele Fornaro, Laura Orsolini, Felice Iasevoli, Carmine Tomasetti, Andrea De Bartolomeis, Nicola Serroni, Alessandro Valchera, Alessandro Carano, Federica Vellante, and et al. 2017. "The Role of Inhaled Loxapine in the Treatment of Acute Agitation in Patients with Psychiatric Disorders: A Clinical Review" International Journal of Molecular Sciences 18, no. 2: 349. https://doi.org/10.3390/ijms18020349