Alejandro Alva
This is a prospective, multicenter, open-label, single-arm study evaluating ERZOFRI (paliperidone palmitate) 351 mg administered every 4 weeks as maintenance treatment in approximately 40 adults with schizophrenia who experience symptom worsening before their next scheduled monthly injection despite receiving paliperidone palmitate 234 mg every 4 weeks. Participants will receive ERZOFRI 351 mg on Day 1, Week 4, and Week 8 and will complete an end-of-study assessment at Week 12. The study will evaluate changes in clinical severity over 12 weeks and will also assess movement-related side effects and sexual functioning.
Inclusion Criteria: 1. Adults aged 18-65 years with a DSM-5 diagnosis of schizophrenia. 2. Currently receiving monthly paliperidone palmitate long-acting injectable (INVEGA SUSTENNA or ERZOFRI) at a dose of 234 mg every 4 weeks (Q4W) for at least 3 consecutive months before Screening. 3. Clinician-documented symptom breakthrough, destabilization, or functional deterioration occurring before the scheduled 4-week injection interval during at least 2 of the 3 most recent monthly injection cycles (not necessarily consecutive). Documentation may include progress notes indicating symptom worsening…
Paliperidone palmitate extended-release injectable suspension (ERZOFRI) 351 mg administered by intramuscular injection on Day 1, Week 4, and Week 8. The Day 1 injection will be administered in the deltoid muscle; subsequent injections may be administered in the deltoid or gluteal muscle.