J&J Submits Application for First Twice-Yearly Schizophrenia Treatment: Paliperidone Palmitate 6-Month (PP6M) Long-Acting Injection

November 03, 2020 News /Bio ValleyBIOON/ -- Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (JNJ), recently announced that it has submitted to the U.S. Food and Drug Administration (FDA) submitted a supplemental New Drug Application (sNDA) seeking approval of the six-monthly paliperidone palmitate long-acting injectable (PP6M) for the treatment of adult patients with schizophrenia. Janssen plans to submit a Marketing Authorization Application (MAA) for PP6M to the European Medicines Agency (EMA) in the coming months.

If approved, PP6M will become the first and only long-acting injectable (LAI) medication for schizophrenia administered twice yearly. PP6M is indicated solely for patients with schizophrenia whose condition has stabilized following treatment with short-acting paliperidone palmitate (PP1M or PP3M), with the aim of reducing injection frequency.

Dr. Bill Martin, Global Therapeutic Area Head of Neuroscience in Janssen’s R&D department, stated: “Janssen’s foundation in neuroscience began with the research and development of new treatment options for schizophrenia, and this application builds upon a 60-year commitment. We designed this unique dosing regimen to allow patients with schizophrenia and their healthcare teams to focus less on medication intervals and more on other aspects of their treatment plan, such as psychosocial interventions. We look forward to working with”FDAcollaboration to add a six-month long-acting injectable to our paliperidone palmitate product portfolio.”

Dr. Mathai Mammen, Global Head of Research and Development at Janssen, stated, “Antipsychotic medications play a critical role in managing the symptoms of schizophrenia; however, nonadherence to prescribed regimens has become a globally recognized challenge. Addressing this challenging aspect of treatment has been the catalyst for our research and development of long-acting injectable therapies for patients with schizophrenia.””

This sNDA is based on the results of the Route 6 study, a randomized, double-blind, non-inferiority Phase 3 global trial that enrolled 702 adult patients with schizophrenia from 20 countries. The data demonstrated that, in both the intent-to-treat (ITT) and per-protocol (PP) analysis sets, PP6M showed non-inferiority to paliperidone palmitate administered once every three months (PP3M) for the primary endpoint of time to relapse at the end of the 12-month study period. The safety profile of PP6M observed in the study was consistent with previous studies of paliperidone palmitate administered once monthly (PP1M) and once every three months (PP3M), with no new safety signals identified.

In the United States, the LAI drug portfolio currently approved by Janssen for the treatment of adult schizophrenia includes Risperdal Consta (risperidone, administered every 2 weeks), Invega Sustenna® (PP1M, paliperidone palmitate, administered once monthly), and Invega Trinza® (PP3M, paliperidone palmitate, administered every 3 months). All these medications are administered by healthcare professionals in a clinical setting.

Invega Sustenna® (PP1M) is a prescription medication administered by healthcare professionals via once-monthly injection for the treatment of adult patients with schizophrenia. Invega Trinza® (PP3M) is a prescription medication administered by healthcare professionals via once-every-three-months injection, indicated for adult patients with schizophrenia who have been treated with Invega Sustenna® (PP1M) for at least four months. (Bioon.com)

Original source: J&J files U.S.application for twice yearly dosing of schizophrenia med