Janssen Pharmaceuticals has submitted supplemental new drug applications (sNDAs) to the US Food and Drug Administration (FDA) seeking approval for its once-monthly atypical long-acting antipsychotic Invega Sustenna (paliperidone palmitate) to treat schizoaffective disorder as either monotherapy or adjunctive therapy.
According to the company, without treatment, symptoms of schizoaffective disorder are complex and disabling.
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There are currently limited treatment options approved for managing the symptoms of depression, mania and psychosis associated with the condition.
Invega Sustenna is the first long-acting injection to be evaluated for treatment of schizoaffective disorder and and if approved it will be the only injection indicated for this condition.
In July 2009, Invega Sustenna was approved by the FDA as the first once-monthly atypical long-acting medication for treatment of schizophrenia.
Janssen vice-president of US neuroscience medical affairs Michelle Kramer said there is a significant need for additional treatment options for the one million Americans with schizoaffective disorder.
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By GlobalData“Having pioneered the development of atypical long-acting treatments for mental illness, Janssen is proud to expand our commitment to mental health with the submission of the sNDAs for what could potentially be the first once-monthly therapy for schizoaffective disorder,” Kramer said.
The submission is based on data from a 15-month trial that found Invega Sustenna met its primary endpoint of delayed time to and reduced risk of relapse compared with placebo and demonstrated significant efficacy in manic and depressive mood symptoms and psychosis.
In the trial, key secondary endpoint of improving and maintaining patient functioning were also met.
Adverse events occurring in greater than 5% of patients in either group of the trial included weight gain, insomnia, worsening of schizoaffective disorder, headache and nasopharyngitis, which is the common cold.
Schizoaffective disorder is a mental condition characterised by a loss of contact with reality psychosis and mood symptoms of depression and/or mania, and the exact cause of this disorder is unknown.
Image: Following FDA approval, ATX-101 will be the first-in-class submental contouring injectable drug. Photo: courtesy of Baitong333/ freedigitalphotos.net.
