NDAINHALATIONPOWDER
Approved
Dec 2012
Lifecycle
Post-LOE
Competitive Pressure
35/100
Clinical Trials
5
Data completeness
4/8 — Partial
ADASUVE (loxapine) by Teva is clinical pharmacology pharmacodynamics: pharmacologically, loxapine is an antipsychotic for which the exact mode of action has not been established. First approved in 2012.
Drug data last refreshed 33m ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ADASUVE is an inhaled powder formulation of loxapine, an antipsychotic that acts on subcortical inhibitory areas to produce tranquilization and suppress aggressive behavior. It is indicated for acute agitation in patients with schizophrenia or bipolar disorder. The drug achieves sedation within 20–30 minutes, with peak effects at 1.5–3 hours and duration through 12 hours.
LOE ApproachingPost-LOE
Product is within 0.1 years of loss of exclusivity; expect reduced commercial investment and team contraction focused on transition planning.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacodynamics: Pharmacologically, loxapine is an antipsychotic for which the exact mode of action has not been established. However, changes in the level of excitability of subcortical inhibitory areas have been observed in several animal species in association with such…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
A Study of Staccato Loxapine (ADASUVE®) for Inhalation
Started Dec 2019
150 enrolled
Psychomotor AgitationSchizophreniaBipolar Disorder
Phase IV to Evaluate the Safety of Self-administered ADASUVE® in Agitated Patients Outside the Hospital Setting
Started Sep 2016
323 enrolled
Agitation
Naturalistic Adasuve Clinical Trial Study
Started Apr 2016
100 enrolled
Agitation
Study to Assess the Safety and Pharmacokinetics of ADASUVE® at Doses of 2.5, 5, or 10 mg in Children and Adolescents (10 Through 17 Years of Age) With Any Condition Warranting Chronic Use of an Antipsychotic Medication
Started Jul 2014
30 enrolled
BiPolar
Fasting Study of Loxapine Succinate Capsules 25 mg and Loxitane® Capsules 25 mg
Started Jan 2003
53 enrolled
Healthy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.