Monthly Extended-Release Risperidone (RBP-7000) in the Treatment of Schizophrenia: Results From the Phase 3 Program

Area of Science:

• Psychiatry
• Pharmacology
• Clinical Trials

Background:

• Schizophrenia treatment often involves daily oral medication.
• Extended-release injectable formulations offer potential for improved adherence and sustained therapeutic levels.
• RBP-7000 is a novel, once-monthly subcutaneous risperidone formulation.

Purpose of the Study:

• To evaluate the long-term safety and tolerability of RBP-7000 (120 mg monthly SC) in adults with schizophrenia.
• To assess the maintenance of clinical effectiveness over 52 weeks.

Main Methods:

• A 52-week, Phase 3, open-label study (NCT02203838) enrolled 500 participants (92 rollover, 408 de novo).
• Participants received up to 13 monthly SC injections of RBP-7000 120 mg.
• Safety was assessed via adverse events, injection-site reactions, vital signs, labs, ECG, EPS, and suicidality. Effectiveness was measured by PANSS and CGI-S.

Main Results:

• 73.4% of participants reported treatment-emergent adverse events, most commonly injection-site pain (13.0%) and weight increase (12.8%).
• Over 80% experienced no injection-site reactions. No significant changes in vital signs, labs, ECG, EPS, or suicidality were observed.
• Mean PANSS scores improved in rollover participants and remained stable in de novo participants over 12 months.

Conclusions:

• RBP-7000 demonstrated a favorable safety and tolerability profile, comparable to oral risperidone, with manageable injection-site reactions.
• The formulation provided sustained symptom control, with continued improvement or stability in PANSS scores over 52 weeks.
• RBP-7000 represents a viable long-term treatment option for schizophrenia patients.