Evaluate TV-46000 as Maintenance Treatment in Adult and Adolescent Patients With Schizophrenia

Inclusion Criteria:

- The patient has a diagnosis of schizophrenia for >1 year and has had ≥1 episode of
relapse in the last 24 months.

- The patient has been responsive to an antipsychotic treatment (other than clozapine)
in the past year based on discussions with family members or healthcare professionals.

- The patient has a stable place of residence for the previous 3 months before
screening, and changes in residence are not anticipated over the course of study
participation.

- The patient has no significant life events that could affect study outcomes expected
throughout the period of study participation.

- Women of childbearing potential and sexually-active female adolescents must agree not
to try to become pregnant, and, unless they have exclusively same-sex partners, must
agree to use a highly effective method of contraception, and agree to continue use of
this method beginning 1 month before the first administration of study drugs and for
the duration of the study and for 120 days after the last injection of study drug.

- The patient, if adult or adolescent male, is surgically sterile, or, if capable of
producing offspring, or has exclusively same-sex partners or is currently using an
approved method of birth control and agrees to the continued use of this method for
the duration of the study (and for 120 days after the last dose of study drug). Male
patients with sex partners who are women of childbearing potential must use condoms
even if surgically sterile

- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

- The patient has a current clinically significant Diagnostic and Statistical Manual of
Mental Disorders, 5th Edition (DSM-5) diagnosis other than schizophrenia, including
schizoaffective 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 patient is currently on clozapine or received electroconvulsive therapy in the
last 12 months.

- The patient has a history of epilepsy or seizures, neuroleptic malignant syndrome,
tardive dyskinesia, or other medical condition that would expose the patient to undue
risk.

- The patient has a positive serology for human immunodeficiency virus (HIV)-1, HIV-2,
hepatitis B surface antigen, and/or hepatitis C.

- The patient has current or history of known hypersensitivity to risperidone or any of
the excipients of TV-46000 or the oral formulation of risperidone used in the
stabilization phase.

- The patient has a substance use disorder, including alcohol and benzodiazepines but
excluding nicotine and caffeine.

- The patient has previously participated in a Teva-sponsored clinical study with
TV-46000.

- The patient is a pregnant or lactating female.

- The patient has any disorder that may interfere with drug absorption, distribution,
metabolism, or excretion (including gastrointestinal surgery).

- The patient has used an investigational drug within 3 months prior to screening or has
participated in a non-drug clinical trial within 30 days prior to screening.

- Additional criteria apply, please contact the investigator for more information