Study to Evaluate TV-46000 as Maintenance Treatment in Adult and Adolescent Participants With Schizophrenia

Inclusion Criteria:

• The participant has a diagnosis of schizophrenia for >1 year and has had ≥1 episode ofrelapse in the last 24 months.
• The participant has been responsive to an antipsychotic treatment (other thanclozapine) in the past year based on discussions with family members or healthcareprofessionals.
• The participant has a stable place of residence for the previous 3 months beforescreening, and changes in residence are not anticipated over the course of studyparticipation.
• The participant has no significant life events that could affect study outcomesexpected throughout the period of study participation.
• Women of childbearing potential and sexually-active female adolescents must agree notto try to become pregnant, and, unless they have exclusively same-sex partners, mustagree to use a highly effective method of contraception, and agree to continue use ofthis method beginning 1 month before the first administration of study drugs and forthe duration of the study and for 120 days after the last injection of study drug.
• The participant, if adult or adolescent male, is surgically sterile, or, if capable ofproducing offspring, or has exclusively same-sex partners or is currently using anapproved method of birth control and agrees to the continued use of this method forthe duration of the study (and for 120 days after the last dose of study drug). Maleparticipants with sex partners who are women of childbearing potential must usecondoms even if surgically sterile
• Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

• The participant has a current clinically significant Diagnostic and Statistical Manualof Mental Disorders, 5th Edition (DSM-5) diagnosis other than schizophrenia, includingschizoaffective disorder, major depressive disorder, bipolar disorder, delirium,dementia, or amnestic or other cognitive disorders, or borderline, paranoid,histrionic, schizotypal, schizoid, or antisocial personality disorder.
• The participant is currently on clozapine or received electroconvulsive therapy in thelast 12 months.
• The participant has a history of epilepsy or seizures, neuroleptic malignant syndrome,tardive dyskinesia, or other medical condition that would expose the participant toundue risk.
• The participant has a positive serology for human immunodeficiency virus (HIV)-1,HIV-2, hepatitis B surface antigen, and/or hepatitis C.
• The participant has current or history of known hypersensitivity to risperidone or anyof the excipients of TV-46000 or the oral formulation of risperidone used in thestabilization phase.
• The participant has a substance use disorder, including alcohol and benzodiazepinesbut excluding nicotine and caffeine.
• The participant has previously participated in a Teva-sponsored clinical study withTV-46000.
• The participant is a pregnant or lactating female.
• The participant has any disorder that may interfere with drug absorption,distribution, metabolism, or excretion (including gastrointestinal surgery).
• The participant has used an investigational drug within 3 months prior to screening orhas participated in a non-drug clinical trial within 30 days prior to screening.
• Additional criteria apply, please contact the investigator for more information