Janssen announced that the Food and Drug Administration (FDA) has approved the supplemental New Drug Applications (sNDAs) for Invega Sustenna (paliperidone palmitate) as either monotherapy or adjunctive therapy in the treatment of schizoaffective disorder. Invega Sustenna is the first once-monthly treatment for schizoaffective disorder to be approved as monotherapy.
The new approval is supported by data from a 15-month long-term maintenance study that studied the ability to delay relapse in schizoaffective disorder. Study results showed that patients treated with Invega Sustenna experienced a statistically significant delay in relapse due to mood (depression and mania) and psychotic symptoms of schizoaffective disorder vs. placebo. Invega Sustenna was also approved as adjunctive therapy to mood stabilizers and antidepressants.
Invega Sustenna is a once-monthly injection already approved for the acute and maintenance treatment of schizophrenia. Paliperidone is the major active metabolite of risperidone. The mechanism of action of paliperidone is unknown. However, it has been proposed that its therapeutic activity in schizophrenia is mediated through a combination of central dopamine Type 2 (D2) and serotonin Type 2 (5HT2A) receptor antagonism.
Bron: Empr.com / Medzine