Efficacy and Safety of Loxapine in Acute Agitation: A Systematic Review of Interventional Studies. To assess the efficacy and safety of loxapine in acute agitation. PubMed, Cochrane database, EMBASE, PsycINFO, and ClinicalTrials.gov were searched to identify relevant articles published in English or French from inception to March 15, 2022. The term "Loxap*" was searched in titles and abstracts . Interventional studies that compared the effectiveness of loxapine to any other intervention (including another administration route or dosage of loxapine, other drugs, and placebo) in acute agitation were included. From the 1,435 articles initially identified, and after the assessment of 73 full texts, 7 articles were selected, encompassing 1,276 participants. Two reviewers independently extracted data
Loxapine An official website of the United States government Here's how you know Log inAccess keysNCBI HomepageMyNCBI HomepageMain ContentMain NavigationBookshelfSearch databaseBooksAll DatabasesAssemblyBiocollectionsBioProjectBioSampleBooksClinVarConserved DomainsdbGaPdbVarGeneGenomeGEO DataSetsGEO ProfilesGTRHomoloGeneIdentical Protein GroupsMedGenMeSHNLM and EffectsSummary of Use during LactationBecause no information is available on the use of loxapine during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.Drug LevelsMaternal Levels. Relevant published information was not found as of the revision date.Infant Levels. Relevant published information was not found as of the revision date.Effects in Breastfed
Adasuve (loxapine) 13 December 2012 EMA/91055/2013 Committee for Medicinal Products for Human Use (CHMP) Assessment report Adasuve International non-proprietary name: loxapine Procedure No. EMEA/H/C/002400 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Assessment report Page 9/91 2. Scientific discussion 2.1. Introduction This is a complete, Article 8(3) application for ADASUVE (loxapine) for a known active substance (loxapine) through the centralised procedure. The product is intended for prescription only. Loxapine is an antipsychotic agent belonging to the dibenzoxazepine class. The antipsychotic effects of Loxapine may
Loxapine, an antipsychotic drug, suppresses intracellular multiple-antibiotic-resistant Salmonella enterica serovar Typhimurium in macrophages. The emergence of multiple-antibiotic-resistant (MAR) Salmonella has been a serious threat worldwide. Salmonella can invade into host cells and evade the attacks of host humoral defenses and antibiotics. Thus, a new antibacterial agent capable of inhibiting intracellular Salmonella is highly needed. The anti-intracellular activity and cytotoxicity of drugs on intracellular bacteria and macrophages were assayed using intracellular CFU assay and MTT cell viability assay, respectively. The uptake of gentamicin into macrophage and the effect of autophagy inhibitor on loxapine's anti-intracellular Salmonella activity were assessed by using image-based
Adasuve (loxapine) inhalation powder Drug Approval Package: Adasuve (loxapine) NDA #022549 Drug Approval Package Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links * * * U.S. Food & Drug Administration * Follow FDA * En EspañolSearch FDA * Home * Food * Drugs * Medical Devices * Radiation-Emitting Products * Vaccines, Blood & Biologics * Animal & Veterinary * Cosmetics * Tobacco ProductsDrug Approval Package * * * * FDA Home * Drugs * Drug Approvals and Databases * Drugs@FDA-Adasuve (loxapine) inhalation powder 10mgCompany: Alexza Pharmaceuticals, Inc.Application No.: 022549Approval Date: 12/21/2012Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. * Approval Letter(s) (PDF) * Summary
Safety and efficacy of self-administered inhaled loxapine (ADASUVE) in agitated patients outside the hospital setting: protocol for a phase IV, single-arm, open-label trial. There is a need for fast-acting, non-injection antiagitation treatments that are well tolerated and can be used outside of healthcare facilities. In phase II/III trials, an inhaled formulation of loxapine (ADASUVE®), a well -established, first-generation antipsychotic agent, provided rapid control of mild to moderate agitation in the hospital setting. The present study was designed to investigate the safety and efficacy of inhaled loxapine when self-administered outside the hospital setting. This phase IV, multicentre, single-arm, open-label clinical trial is being conducted in five countries in Europe: Spain, Germany, Norway
PLACID study: A randomized trial comparing the efficacy and safety of inhaled loxapine versus intramuscular aripiprazole in acutely agitated patients with schizophrenia or bipolar disorder. The aim of the study was to investigate the efficacy and safety of inhaled loxapine compared with the intramuscular (IM) antipsychotic aripiprazole in acutely agitated patients with schizophrenia or bipolar I loxapine 9.1 mg or IM aripiprazole 9.75 mg (≥ 2 h between doses) during the 24-h study period. The primary efficacy endpoint was time to response (CGI-Improvement score 1 [very much improved] or 2 [much improved]). The primary analysis included randomized patients who provided informed consent (full analysis set [FAS]); the safety analysis included all patients who received study medication. The FAS
Rationale and design of the PLACID study: a randomised trial comparing the efficacy and safety of inhaled loxapine versus IM aripiprazole in acutely agitated patients with schizophrenia or bipolar disorder. The management of acute agitation manifesting in patients with schizophrenia or bipolar disorder requires swift pharmacological intervention to provide rapid symptomatic relief and prevent escalation to aggression and violence. Antipsychotic medications are widely used in this setting and the availability of an inhaled formulation with deep lung absorption of the antipsychotic loxapine has the potential to deliver a faster onset of therapeutic effect than the available intramuscular formulations of antipsychotics. The efficacy of inhaled loxapine and the alternative antipsychotic
Response to inhaled loxapine in patients with schizophrenia or bipolar I disorder: PANSS-EC responder analyses 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 placebo at 2 h and at each assessment time point for both doses. 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. S.Z. is a member of the speakers bureau for Grupo
The in Vitro Actions of Loxapine on Dopaminergic and Serotonergic Receptors. Time to Consider Atypical Classification of This Antipsychotic Drug? The denomination of typical antipsychotic for loxapine has poor relation to current knowledge of the molecule's relevant modes of action. Competition binding experiments were performed on expressed human recombinant receptors in CHO cells and HEK-293 cells for D1 to D5, 5-HT1A, 5-HT2A, 5-HT2C, 5-HT4, 5-HT6, and 5-HT7. In vitro autoradiographies using [11C]-Raclopride [18F]-Altanserin [18F]-MPPF [11C]-SB207145, and [18F]-2FNQ1P were measured in brain tissue of a male primate followed by addition of increasing doses of loxapine succinate. In cell cultures, the measured Kb confirmed high affinity of loxapine for the D2; intermediate affinity
Inhaled Loxapine for Agitation in Intoxicated Patients: A Case Series Episodes of agitation are frequent in intoxicated patients who have a substance use disorder, a psychiatric disorder or both (dual diagnosis). For managing the agitation, it is necessary to act promptly in a safe environment and addressing any underlying etiology. Inhaled loxapine improves symptoms of agitation in adults with psychiatric disorders (eg, schizophrenia) within 10 minutes of administration. Recently, some reports have documented the usefulness of loxapine in dual diagnoses patients with agitation. However, the efficacy of loxapine in intoxicated patients has not been deeply addressed. This report describes a case series of 12 patients (with addiction or dual disorder) who received inhaled loxapine for symptoms
Inhaled Loxapine for the Treatment of Psychiatric Agitation in the Prehospital Setting: A Case Series Rapid and effective control of agitated patients is crucial for ensuring their safety and proper management. We present a case series of 12 agitated psychiatric patients who were suitable for treatment with inhaled loxapine in the prehospital emergency setting. Two refused its administration and two required additional treatment. Loxapine was effective within 2-10 minutes, with no adverse effects or sedation. In our experience the use of inhaled loxapine enabled rapid and non-coercive control of agitation in most psychiatric patients, allowing us to avoid mechanical restraint and injectable drugs, and facilitating the transportation and transfer of the patients.
Clinical Trial Simulations and Pharmacometrics Analysis in Pediatrics: Application to Inhaled Loxapine in Children and Adolescents Loxapine for inhalation is a drug-device combination product approved in adults for the acute treatment of agitation associated with schizophrenia or bipolar I disorder. The primary objective of this study was to develop a clinical trial protocol to support a phase I scaling to account for body size effects. Based on this pediatric model, age-appropriate regimens to achieve loxapine exposures similar to the ones associated with therapeutic effect in the adult studies were identified via trial simulation. D-optimal design and power analysis were conducted to identify optimal pharmacokinetic sampling times and sample size, respectively. The developed clinical trial
Loxapine to control agitation during weaning from mechanical ventilation Weaning from mechanical ventilation (MV) may be impeded by the occurrence of agitation. Loxapine has the ability to control agitation without affecting spontaneous ventilation. The aim of this study was to establish whether loxapine would reduce MV weaning duration in agitated patients. We performed a multicentre, double -blind, placebo-controlled, parallel group, randomised trial. Patients who were potential candidates for weaning but exhibited agitation (Richmond Agitation-Sedation Scale score ≥ 2) after sedation withdrawal were randomly assigned to receive either loxapine or placebo. In case of severe agitation, conventional sedation was immediately resumed. The primary endpoint was the time between first
The Role of Inhaled Loxapine in the Treatment of Acute Agitation in Patients with Psychiatric Disorders: A Clinical Review Loxapine is a first generation antipsychotic, belonging to the dibenzoxazepine class. Recently, loxapine has been reformulated at a lower dose, producing an inhaled powder that can be directly administered to the lungs to treat the agitation associated with psychiatric disorders, such as schizophrenia and bipolar disorder. Thus, the aim of this narrative and clinical mini-review was to evaluate the efficacy and tolerability of inhaled loxapine in the treatment of acute agitation in patients with psychiatric disorders. The efficacy of inhaled loxapine has been evaluated in one Phase II trial on patients with schizophrenia, and in two Phase III trials in patients
Inhaled loxapine and intramuscular lorazepam in healthy volunteers: a randomized placebo-controlled drug-drug interaction study. Pharmacodynamic effects and safety of single-dose inhaled loxapine administered via the Staccato(®) system and intramuscular (IM) lorazepam in combination versus each agent alone were compared in a randomized, double-blind, crossover study in healthy volunteers . Subjects received: inhaled loxapine 10 mg + IM lorazepam 1 mg; inhaled loxapine 10 mg + IM placebo; IM lorazepam 1 mg + Staccato placebo in random order, each separated by a 3-day washout. Primary endpoints were maximum effect (minimum value) and area under the curve (AUC) from baseline to 2 h post treatment for respirations/min and pulse oximetry. Least-squares means (90% confidence interval [CI
Inhaled loxapine for the urgent treatment of acute agitation associated with schizophrenia or bipolar disorder. Acute agitation is a serious complication of schizophrenia and bipolar disorder, which may escalate quickly to aggressive behavior. Rapid treatment is therefore important to calm and stabilize the patient, reducing the potential for harm to the patient and others, and allowing further assessment. Current guidelines suggest that where pharmacologic intervention is indicated, medication should preferably be non-invasive, should have a rapid onset and should control aggressive behavior in the short term without compromising the physician-patient relationship in the long term. This article presents an overview of a new inhaled formulation of the established antipsychotic loxapine, which
Loxapine and Cyproheptadine Combined Limit Clozapine Rebound Psychosis and May Also Predict Clozapine Response Clozapine has been consistently shown to be superior to other antipsychotics in the treatment of psychosis. However, clozapine usage has been limited due to required routine blood monitoring and the potential for life threatening side effects. We report a case of a 66-year-old female patient, who developed clozapine-induced agranulocytosis after 10 weeks of clozapine treatment and was subsequently successfully treated with a combination of loxapine and cyproheptadine. The combination is thought to mimic the pharmacological profile of clozapine, rendering it as a possible alternative to traditional clozapine treatment.
A randomized, placebo-controlled repeat-dose thorough QT study of inhaled loxapine in healthy volunteers. This randomized, double-blind, active- and placebo-controlled, crossover, thorough QT study assessed the effect of two inhaled loxapine doses on cardiac repolarization as measured by corrected QT (QTc) interval in healthy subjects (ClinicalTrials.gov NCT01854710). Subjects received two doses of inhaled loxapine (10 mg) 2 hours apart + oral placebo, two doses of inhaled placebo + oral placebo, or two doses of inhaled placebo + oral moxifloxacin (400 mg; positive control), with ≥ 3 days washout between treatments. Two-sided 90% confidence intervals (CIs) were calculated around least-squares mean predose placebo-subtracted individually corrected QT durations (ΔΔQTcIs) at 12 time points throughout