FDA Approval and Indication
On July 27, 2018, the FDA granted approval for Perseris, marking a significant milestone in the treatment landscape for schizophrenia. Developed by Indivior, this extended-release injectable suspension was specifically indicated for the treatment of schizophrenia in adults. This approval provides a once-monthly, long-acting injectable (LAI) option for patients and healthcare providers. The approval was based on successful clinical trials, which showed statistically significant improvements in symptom scores compared to a placebo.
Mechanism of Action and Administration
Perseris is a formulation of risperidone, an atypical antipsychotic. Unlike other long-acting risperidone injectables, Perseris uses a unique delivery system that allows it to be injected subcutaneously, just under the skin, in the abdomen or back of the upper arm. This technology eliminates the need for a loading dose or supplemental oral risperidone, as clinically relevant drug levels are reached shortly after the first injection. The injection must be administered by a healthcare professional in a clinic setting.
Important Safety Information and Warnings
As part of its approval, the FDA requires that the prescribing information for Perseris include a boxed warning regarding the increased risk of death in elderly patients with dementia-related psychosis. Perseris is explicitly not approved for use in this patient population. Several other serious potential side effects and warnings are also associated with Perseris use, consistent with other antipsychotic medications.
Key Safety Concerns
- Cerebrovascular Adverse Reactions: An increased risk of cerebrovascular events, such as stroke, has been observed in elderly patients with dementia.
- Neuroleptic Malignant Syndrome (NMS): This rare but serious condition can cause high fever, severe muscle stiffness, confusion, and other symptoms.
- Tardive Dyskinesia: Patients may experience uncontrolled, involuntary movements of the face and body, which may become permanent.
- Metabolic Changes: Monitoring is necessary for potential issues like hyperglycemia, diabetes, weight gain, and changes in blood fat levels.
- Hyperprolactinemia: Increases in the hormone prolactin can occur, leading to side effects such as irregular menstrual periods, lactation, or erectile dysfunction.
- Orthostatic Hypotension: A sudden drop in blood pressure when standing up, which can cause dizziness or fainting.
- Blood Cell Abnormalities: Low white blood cell count (leukopenia/neutropenia) has been reported and may require monitoring.
- Cognitive and Motor Impairment: Patients should be cautious when operating machinery or driving until they understand how the medication affects them.
Perseris Compared to Other Risperidone Formulations
Perseris is one of several risperidone products available, including oral formulations and another long-acting injectable, Risperdal Consta. Their differences in approval, administration, and dosage are important considerations for treatment.
| Feature | Perseris | Risperdal Consta | Oral Risperidone |
|---|---|---|---|
| FDA Approval | Approved July 27, 2018 | Approved October 29, 2003 | First approved December 29, 1993 |
| Indication(s) | Schizophrenia in adults | Schizophrenia and Bipolar I disorder | Schizophrenia, Bipolar I disorder, Autism-related irritability |
| Dosage Frequency | Once monthly | Every two weeks | Once or twice daily |
| Administration | Subcutaneous (under the skin) | Intramuscular (into the muscle) | Oral (tablet, solution, orally disintegrating tablet) |
| Loading Dose Needed? | No | Yes, plus 3 weeks of oral supplementation | Not applicable |
| Administered By | Healthcare professional | Healthcare professional | Patient |
Patient Considerations and Efficacy
Before initiating Perseris, healthcare providers establish a patient's tolerability to oral risperidone. This step ensures the patient does not have severe adverse reactions to the medication itself. The once-monthly administration offers a benefit for patients who may struggle with daily medication adherence, a common challenge in schizophrenia. The controlled, extended release helps to maintain consistent therapeutic levels of the drug, potentially reducing the risk of symptom relapse associated with missed doses. A key feature of Perseris is its unique subcutaneous delivery system, which forms a depot under the skin that gradually releases the medication over a month. While a small, temporary lump can form at the injection site, it typically decreases over time and patients are advised not to massage the area.
According to an official FDA approval package, the efficacy of Perseris was established through an 8-week, randomized, double-blind, placebo-controlled Phase 3 study involving 354 patients with schizophrenia. The results showed a statistically significant improvement in the Positive and Negative Syndrome Scale (PANSS) total score, a key measure of symptom severity. For more detailed information on the approval process and clinical data, one can refer to the official FDA Approval Package for Perseris.
Conclusion
In summary, Risperdal Perseris is indeed FDA approved, with its approval granted on July 27, 2018. Its sole approved indication is the treatment of schizophrenia in adults. As a long-acting, once-monthly subcutaneous injectable, it represents an important option for patients who benefit from consistent medication levels and face challenges with daily oral adherence. However, its use is accompanied by important safety information, including a boxed warning regarding risks for elderly patients with dementia-related psychosis and other potential side effects that necessitate careful monitoring by a healthcare provider. Patients should always consult with their healthcare team to determine if Perseris is the right treatment for their specific needs.
