Kelli R. Franzenburg, PhD

Evaluation of the Innovative Drug Delivery Technology Utilized in TV-46000, a Subcutaneous Long-acting Injectable Risperidone Formulation

Abstract: Background TV-46000 is a risperidone extended-release suspension for subcutaneous administration in development for treatment of patients with schizophrenia. TV-46000 is based o...

Kelli R. Franzenburg , PhD;

01/19/2023

Behavioral-, Neurologic-, Metabolic-, Endocrine-, and Cardiovascular-Related Adverse Events and Assessments in Patients With Schizophrenia Treated With TV-46000

TV-46000 is an FDA-approved long-acting subcutaneous antipsychotic (LASCA) formulation of risperidone that was shown to reduce time to impending relapse in patients with schizophrenia. Th...

Kelli R. Franzenburg , PhD;

10/26/2023

Impact of Treatment With TV-46000, a Long-Acting Subcutaneous Antipsychotic (LASCA), at Different Stages of Schizophrenia: a Post Hoc Analysis

TV-46000 is an FDA-approved long-acting subcutaneous antipsychotic (LASCA) formulation of risperidone that has been shown to reduce time to impending relapse in patients with schizophreni...

Kelli R. Franzenburg , PhD;

10/26/2023

Introducing S.C.O.P.E.™: Schizophrenia Clinical Outcome Scenarios and Patient-Provider Engagement—An Interactive Digital Platform to Educate on Schizophrenia Care

Educational initiatives targeting common clinical dilemmas encountered by clinicians managing patients with schizophrenia may clarify appropriate use of long-acting injectable antipsychot...

Kelli R. Franzenburg , PhD;

10/26/2023

Long-term Safety, Tolerability, and Effectiveness of TV-46000, a Long-Acting Subcutaneous Antipsychotic (LASCA), in Patients With Schizophrenia (SHINE)

TV-46000 is a long-acting subcutaneous antipsychotic (LASCA). The SHINE study evaluated the long-term safety, tolerability, and effect of TV-46000 once monthly (q1m) and once every two mo...

Kelli R. Franzenburg , PhD;

10/26/2023

SOLARIS Protocol: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Trial of TV-44749 for Subcutaneous Use (Olanzapine for Extended-Release Injectable Suspension Use) in Adults With Schizophrenia

Intramuscular long-acting injectable olanzapine is approved for treatment of schizophrenia in adults but has an associated risk for post-injection delirium/sedation syndrome. The Subcutan...

Kelli R. Franzenburg , PhD;

10/26/2023

TV-46000—a Long-Acting Subcutaneous Antipsychotic (LASCA) for the Treatment of Schizophrenia: Local Tolerability and Injection Site Reactions

TV-46000 is a long-acting subcutaneous antipsychotic (LASCA) that combines risperidone and an innovative delivery technology in a suspension suitable for subcutaneous administration in th...

Kelli R. Franzenburg , PhD;

10/26/2023