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FDA Approves Once-Monthly Invega Sustenna (Paliperidone Palmitate) for Schizoaffective Disorder

Agency nod based on positive long-term data

The FDA has approved supplemental new drug applications (sNDAs) for the once-monthly atypical long-acting antipsychotic agent Invega Sustenna (paliperidone palmitate, Janssen Pharmaceuticals) to treat schizoaffective disorder (SD) as either monotherapy or adjunctive therapy.

The sNDAs received priority review, which is a designation for drugs that, if approved, would offer significant improvement in the treatment of serious conditions.

Invega Sustenna is the only once-monthly medication indicated to treat SD as monotherapy.

The FDA’s approval was based on data from a 15-month period in a long-term maintenance study that measured the ability of Invega Sustenna to delay relapse in patients with SD. The study found that treatment with Invega Sustenna resulted in a statistically significant delay in relapse due to mood (depression and mania) and psychotic symptoms of SD compared with placebo. The results were presented in May 2014 at the 167th annual meeting of the American Psychiatric Association.

Few large, controlled studies have examined the clinical characteristics of SD and long-term treatment options. The new trial, which included a 6-month open-label treatment period and a 15-month double-blind period, was the first registration study to investigate maintenance treatment with a long-acting injectable in patients with SD. In addition to the approval of Invega Sustenna as monotherapy for this disorder, it is indicated as adjunctive therapy to mood stabilizers or antidepressants.

The most common adverse events observed in patients treated with Invega Sustenna included injection-site reactions, somnolence/sedation, dizziness, akathisia, and extrapyramidal disorder.

SD is a mental illness with an overlap of psychotic and mood symptoms. Psychotic symptoms include delusions or hallucinations, and mood symptoms include depression and mania. The exact cause of SD is unknown. The disorder is diagnosed via a mental health assessment of symptoms over an extended period conducted by a licensed mental health professional. The full constellation of symptoms and the relevant diagnostic criteria should be consulted by clinicians and are available in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5 or current version).

SD is a complex condition that is generally treated with a combination of medications. In 2009, Invega (paliperidone, Janssen) was the first atypical antipsychotic agent approved to treat SD. Other than Invega and Invega Sustenna, no antipsychotic medications are indicated to treat SD in the U.S., and no widely accepted guidelines for treatment of the disease are available.

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Invega Sustenna is not approved for the treatment of patients with dementia-related psychosis.

Source: Janssen; November 13, 2014.

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