Regulatory Approval Sought for Invega Sustenna (Paliperidone Palmitate) for Treatment of Schizoaffective Disorder
New FDA submission based on positive data from 15-month relapse-prevention study
Supplemental new drug applications (sNDAs) have been submitted to the FDA for approval of the once-monthly atypical long-acting antipsychotic Invega Sustenna (paliperidone palmitate, Janssen) for the treatment of schizoaffective disorder as either monotherapy or adjunctive therapy.
Invega Sustenna is the first long-acting injection to be studied for the treatment of schizoaffective disorder and — if approved by the FDA — will be the only long-acting injection indicated to treat that condition. Invega Sustenna was approved by the FDA in July 2009 as the first once-monthly atypical long-acting medication to treat schizophrenia. The drug’s efficacy was established in four short-term studies and one longer-term study in adults.
The NDA applications are based on a 15-month trial in which Invega Sustenna met its primary endpoint of delayed time to and reduced risk of relapse compared with placebo. The treatment also showed significant efficacy in reducing manic and depressive mood symptoms and psychosis, and met the key secondary endpoint of improving and maintaining patient functioning.
The results of this study were presented last week at the 167th annual meeting of the American Psychiatric Association in New York City.
Adverse events occurring in more than 5% of patients in either group included weight gain (Invega Sustenna, 8.5% vs. placebo, 4.7%), insomnia (4.9% vs. 7.1%), worsening of schizoaffective disorder (3.1% vs. 5.9%), headache (5.5% vs. 3.5%) and nasopharyngitis (5.5% vs. 3.5%). The most common movement disorders were akathisia (Invega Sustenna, 3.0% vs. placebo, 1.8%) and tremor (1.2% vs. 2.4%). Thirteen percent of the Invega Sustenna group and 6.0% of the placebo group had an increase of 7% or greater in body weight. Potentially prolactin-related adverse events were reported in 10.4% of patients in the Invega Sustenna group compared with 3.5% of the placebo group.
Schizoaffective disorder is a mental condition characterized by a loss of contact with reality — psychosis — and mood symptoms of depression and/or mania. The exact cause of schizoaffective disorder is unknown. The disorder is generally treated with a complex combination of medications. Besides Invega (paliperidone, Janssen), no antipsychotic medications are approved for the treatment of schizoaffective disorder in the U.S., and no widely accepted treatment guidelines are available. Invega was launched in the U.S. in 2009.
Source: PR Newswire; May 13, 2014.