The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for paliperidone palmitate 6-month (PP6M) for the treatment of adults diagnosed with schizophrenia. If approved, PP6M will be the first and only long-acting injectable (LAI) schizophrenia medication with a twice-yearly dosing regimen.
"Janssen's roots in neuroscience began with research and development of novel therapeutic options for schizophrenia, and this filing builds on that 60-year commitment," said Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Janssen Research & Development, LLC. "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. We look forward to working with the FDA to add a 6-month formulation to our family of paliperidone palmitate products."
The submission is based on the Route 6 Study, a randomized, double-blind, non-inferiority Phase 3 global study that enrolled 702 adults living with schizophrenia from 20 countries. Data showed non-inferior efficacy of PP6M compared to paliperidone palmitate 3-month (PP3M) on the primary endpoint of time to relapse at the end of the 12-month period in both intent-to-treat and per-protocol analysis sets.1 The safety profile observed for PP6M was consistent with previous studies of paliperidone palmitate 1-month (PP1M) and 3-month (PP3M) formulations with no new safety signals emerging.
"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, M.D., Ph.D., Global Head of Janssen Research & Development, LLC. "Addressing this challenging aspect of treatment has been the catalyst for our research and development of long-acting injectable medications for people living with schizophrenia."
PP6M is intended to be used only after patients have been stabilized on a shorter acting formulation of paliperidone palmitate (PP1M or PP3M), with the goal of administering fewer injections. The Janssen U.S. portfolio of LAI medicines currently approved to treat adults with schizophrenia includes RISPERDAL CONSTA (risperidone 2-weekly)2, INVEGA SUSTENNA3 and INVEGA TRINZA4 (PP1M and PP3M formulations, respectively), all of which are administered in a clinical setting by a medical professional.
Janssen plans to submit a Marketing Authorization Application extension to the European Medicines Agency (EMA) for PP6M in the coming months.