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Psych Congress  

Efficacy of Monthly Extended-release Risperidone Injections (RBP-7000) for the Treatment of Schizophrenia: An Analysis of Individual PANSS Items

Authors  

Anne Andorn, MD – Indivior Inc., North Chesterfield, VA; James Graham, PharmD – Indivior Inc., North Chesterfield, VA; Maurizio Fava, MD – Harvard University, Boston, MA; John Csernansky, MD – Northwestern University Evanston, IL; John Newcomer, MD – Washington University School of Medicine, St. Louis, MO; David Walling, PhD – Collaborative Neuroscience Network, LLC, Garden Grove, CA; Sunita Shinde, MD – Indivior Inc., North Chesterfield, VA; Gilbert Muma, PhD – Indivior Inc., North Chesterfield, VA; Christian Heidbreder, PhD – Indivior Inc., North Chesterfield, VA

Sponsor  
Indivior Inc.

Introduction: RBP-7000 (PERSERIS™) is a once-monthly, subcutaneous, extended-release risperidone formulation that is approved for treating schizophrenia in adults and is designed to deliver clinically relevant plasma concentrations on the first day of dosing (with no loading or supplemental dosing).

Methods: In this Phase III study (NCT02109562), adults ages 18–55 years with acute schizophrenia were randomized to monthly injections of placebo, RBP-7000 90 mg, or RBP-7000 120 mg. This post hoc analysis examined the effects of RBP-7000 on the individual items of the PANSS Positive, Negative, and General Psychopathology subscales.

Results: Treatment with RBP-7000 90 mg and 120 mg improved scores on 4 of 7 PANSS Positive items vs placebo: depression hallucinatory behavior, conceptual disorganization, delusions, and suspiciousness/persecution. Additionally, improvements in hostility and excitement scores were observed with RBP-7000 120 mg. RBP-7000 120 mg also improved 2 PANSS Negative item scores vs placebo (emotional withdrawal and passive/apathetic withdrawal), while stereotyped thinking and difficulty in abstract thinking trended toward improvement. Both RBP-7000 90 mg and 120 mg improved 6 of 16 PANSS General Psychopathology item scores vs placebo: depression, active social avoidance, uncooperativeness, poor attention, anxiety, and tension. Additionally, improvements in poor impulse control and somatic concern were observed with RBP-7000 120 mg, while the 90-mg dose improved motor retardation.

Conclusion: Treatment with RBP-7000 90 mg or 120 mg improved many PANSS items across domains. Importantly, treatment with the higher dose (120 mg) improved 2 PANSS Negative items, suggesting RBP-7000 may be useful in addressing difficult-to-treat negative symptoms of schizophrenia.

This poster was presented at the 32nd annual Psych Congress, held Oct. 3-6, 2019, in San Diego, California.

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