The Janssen Pharmaceutical Companies of Johnson & Johnson is seeking US Food and Drug Administration (FDA) approval for the first long-acting injectable (LAI) medication for schizophrenia that would be taken only twice a year.
Janssen has submitted a supplemental New Drug Application (sNDA) to the FDA for paliperidone palmitate 6-month (PP6M) for the treatment of schizophrenia in adults.
"We designed this unique dosing regimen so people with schizophrenia and their healthcare teams can focus less on medication intervals and more on other aspects of their treatment plans, such as psychosocial interventions," said Bill Martin, PhD, Global Therapeutic Area Head, Neuroscience, Janssen Research & Development.
The application is based on a randomized, double-blind, noninferiority Phase 3 study that included 702 adults with schizophrenia from 20 countries. The study showed noninferior efficacy of PP6M, compared to paliperidone palmitate 3-month (PP3M), on the primary endpoint—time to relapse at the end of the 12-month period in both intent-to-treat and per-protocol analysis sets, according to a press release from Janssen.
The safety profile observed for the 6-month formulation was consistent with previous studies of PP3M and paliperidone palmitate 1-month (PP1M), with no new safety signals emerging, according to the statement.
The new formulation is intended to be used only after patients have been stabilized on PP1M or PP3M, with the goal of administering fewer injections.
"Antipsychotic medication plays an important role in schizophrenia symptom control; however, nonadherence to prescribed medicines has been recognized as a problem worldwide," said Mathai Mammen, MD, PhD, Global Head of Janssen Research & Development. "Addressing this aspect of treatment has been the catalyst for our research and development of challenging long-acting injectable medications for people living with schizophrenia."
Janssen submits paliperidone palmitate 6-month (PP6M) Supplemental New Drug Application to US FDA for treatment of schizophrenia in adults [press release]. Titusville, NJ: Janssen Pharmaceutical Companies of Johnson & Johnson; November 2, 2020.