Efficacy and Safety of Loxapine for Inhalation in the Treatment of Agitation in Patients With Schizophrenia

Allen, Michael; Feifel, David; Lesem, Michael D.; Zimbroff, Daniel L.; Ross, Ruth; Munzar, Patrik; Spyker, Daniel A.; Cassella, James V.

doi:10.4088/jcp.10m06011yel

Cited by 94 publications

(64 citation statements)

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“…127 Efficacy results through 24 hours from two randomized, placebo-controlled phase 3 studies of 5 mg and 10 mg Staccato® loxapine revealed that agitation (as measured by the excitatory component of the Positive and Negative Syndrome Scale 128 ) in agitated patients with schizophrenia was significantly reduced versus placebo treatment (p р 0.0001) at 10-20 minutes following administration of the 10-mg dose of Staccato® loxapine. 129,130 A similar rapid response was observed in agitated patients with bipolar disorder who received the same dose. 127 The most common side effects (> 10%) were altered taste, dizziness, and sedation, with no serious treatmentrelated adverse events reported.…”

Section: Unmet Needs In Pharmacological Rapid Tranquilizationsupporting

confidence: 73%

Agitation in the Inpatient Psychiatric Setting

Hankin¹,

Bronstone²,

Koran

2011

Journal of Psychiatric Practice

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Agitation among psychiatric inpatients (particularly those diagnosed with schizophrenia or bipolar disorder) is common and, unless recognized early and managed effectively, can rapidly escalate to potentially dangerous behaviors, including physical violence. Inpatient aggression and violence have substantial adverse psychological and physical consequences for both patients and providers, and they are costly to the healthcare system. In contrast to the commonly held view that inpatient violence occurs without warning or can be predicted by "static" risk factors, such as patient demographics or clinical characteristics, research indicates that violence is usually preceded by observable behaviors, especially non-violent agitation. When agitation is recognized, staff should employ nonpharmacological de-escalation strategies and, if the behavior continues, offer pharmacological treatment to calm patients rapidly. Given the poor therapeutic efficacy and potential for adverse events associated with physical restraint and seclusion, and the potential adverse sequelae of involuntary drug treatment, these interventions should be considered last resorts. Pharmacological agents used to treat agitation include benzodiazepines and first- and second-generation antipsychotic drugs. Although no currently available agent is ideal, recommendations for selecting among them are provided. There remains an unmet need for a non-invasive and rapidly acting agent that effectively calms without excessively sedating patients, addresses the patient's underlying psychiatric symptoms, and is reasonably safe and tolerable. A treatment with these characteristics could substantially reduce the clinical and economic burden of agitation in the inpatient psychiatric setting.

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Section: Unmet Needs In Pharmacological Rapid Tranquilizationsupporting

confidence: 73%

Agitation in the Inpatient Psychiatric Setting

Hankin¹,

Bronstone²,

Koran

2011

Journal of Psychiatric Practice

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“…Oral dosage is between 50 and 200 mg/day. Plasma half-life is approximately 4 h, with a terminal half-life of up to 19 h. For inhaled loxapine, the dose has been found to be effective at 5 or 10 mg per administration and studies allowed up to three doses/24 h [26]. Loxapine is metabolized in the liver and largely excreted through the kidneys.…”

Section: Clinical Pharmacologymentioning

confidence: 98%

Inhaled loxapine for rapid treatment of agitation in schizophrenia and bipolar disorder: an update

Nordstrom¹

2012

Neuropsychiatry

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Agitation is a common presenting problem in emergency departments and treatments currently range from de-escalation techniques to medications, in either oral or intramuscular forms. Oral medications can be diverted and have a relatively long delay of onset. This delay is problematic for agitated patients in that the agitation may escalate prior to onset of action of the medication. This can lead to the need for intramuscular medications or even physical restraints. Regarding intramuscular medications, they tend to work more quickly but are highly invasive. A new delivery system using loxapine is currently being

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“…Efficacy was demonstrated in two pivotal trials in patients with schizophrenia [26,27] and in one trial in patients with bipolar disorder, manic or mixed episode. [28] Effect sizes for the reduction of agitation were comparable with those for intramuscular options.…”

Section: Antipsychoticsmentioning

confidence: 99%

Pharmacological Management of Acute and Persistent Aggression in Forensic Psychiatry Settings

Citrome

Volavka

2011

CNS Drugs

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Aggressive behaviour is common in forensic psychiatric settings. The aetiology of aggressive behaviour is multifactorial and can be driven by psychosis, impulsivity, psychopathy, intoxication, cognitive impairment, or a combination of all of these. Recognition of the different factors behind the aggression can inform medication selection and the relative need for specific environmental and behavioural interventions in a forensic psychiatric setting. Acute agitation needs to be managed quickly and effectively before further escalation of the behavioural dyscontrol occurs. Benzodiazepines and/or antipsychotic medications are often used and can be given intramuscularly to achieve a rapid onset of action. Available are intramuscular preparations of second-generation antipsychotics that have similar efficacy to lorazepam and haloperidol in reducing agitation, but are well tolerated and not associated with the extrapyramidal adverse effects, including akathisia, that can plague the older first-generation antipsychotics. The longer-term management of persistent aggressive behaviour can be quite complex. A major obstacle is that the causality of aggressive events can differ from patient to patient, and also from event to event in the same patient. For patients with schizophrenia and persistent aggressive behaviour, clozapine is recommended both for its superior antipsychotic effect and its specific anti-hostility effect. Mood stabilizers such as valproate may be helpful in instances of poor impulsivity and personality disorders. Other agents that have been successfully used include β-adrenoceptor antagonists (β-blockers) and antidepressants.

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Efficacy and Safety of Loxapine for Inhalation in the Treatment of Agitation in Patients With Schizophrenia

Abstract: ClinicalTrials.gov identifier: NCT00369577.

Cited by 94 publications

References 0 publications

Agitation in the Inpatient Psychiatric Setting

Agitation in the Inpatient Psychiatric Setting

Inhaled loxapine for rapid treatment of agitation in schizophrenia and bipolar disorder: an update

Pharmacological Management of Acute and Persistent Aggression in Forensic Psychiatry Settings

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