A new, unique long-acting injectable for treating schizophrenia may be on the way.
Janssen Pharmaceutical Companies of Johnson & Johnson recently announced their supplemental New Drug Application (sNDA) submission for paliperidone palmitate 6-month (PP6M), a treatment for adults diagnosed with schizophrenia. PP6M will be the first and only long-acting injectable (LAI) medication for schizophrenia with a bi-annual dosing regimen, if approved.
Bill Martin, PhD, Global Therapeutic Area Head, Neuroscience, Janssen Research & Development, LLC, had this to say to the press: “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. 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.”1
Janssen’s submission to the US Food and Drug Administration (FDA) is based on the Route 6 Study, a randomized, double-blind, Phase III global study with 702 adult participants from 20 countries who were diagnosed with schizophrenia. Data showed PP6M’s efficacy in comparison to paliperidone palmitate 3-month (PP3M) in 2 analysis sets, intent-to-treat and per-protocol, for relapse times at the end of the 12-month period. The observed safety profile was consistent with precious studies.
“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, LLC, to the press. “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.”1
An important note on PP6M is that it is intended to be used only after patients are stabilized using another short-acting paliperidone palmitate (PP1M or PP3M). The overall goal is to administer fewer injections to patients.
“We look forward to working with the FDA to add a 6-month formulation to our family of paliperidone palmitate products,” Martin said further.1
To see more on this, watch The Best Solution to Nonadherence.
1. Janssen Submits Paliperidone Palmitate 6-Month (PP6M) Supplemental New Drug Application to US FDA for Treatment of Schizophrenia in Adults. Johnson & Johnson. News release. November 2, 2020. http://johnsonandjohnson.gcs-web.com/news-releases/news-release-details/janssen-submits-paliperidone-palmitate-6-month-pp6m-supplemental