Psychiatry AdvisorErzofri Approved for Schizophrenia, Schizoaffective Disorder

Read the original article

The FDA has approved Erzofri (paliperidone palmitate), a once-monthly injectable atypical antipsychotic, for treating schizophrenia and schizoaffective disorder in adults. This approval, based on studies of a similar paliperidone palmitate formulation, offers a new treatment option for these serious mental health conditions. Erzofri’s approval through the 505(b)(2) pathway highlights the FDA’s approach to expediting access to potentially beneficial treatments while maintaining safety standards.

Key Points:

• Erzofri is approved for schizophrenia and schizoaffective disorder in adults, as monotherapy or adjunct to mood stabilizers or antidepressants
• Administered as a once-monthly intramuscular injection
• Available in 5 dosage strengths: 39 mg/0.25 mL to 351 mg/2.25 mL
• Patients new to paliperidone or risperidone should establish oral tolerability before starting Erzofri
• Common adverse reactions include somnolence/sedation, dizziness, akathisia, and extrapyramidal disorder
• Boxed Warning for increased mortality risk in elderly patients with dementia-related psychosis
• Must be administered by a healthcare provider

A self-controlled case series study of people in Hong Kong with schizophrenia suggests that long-acting injectable antipsychotics (LAIAs) were associated with a lower risk of disease relapse and hospitalization than oral antipsychotics (OAs), without an increased risk of adverse events. (JAMA Psychiatry)

More on Schizophrenia