A supplemental New Drug Application (sNDA) for paliperidone palmitate 6-month (PP6M; Janssen) for the treatment of adults with schizophrenia has been submitted to the Food and Drug Administration (FDA).
PP6M is a long-acting injectable antipsychotic designed to reduce the number of injections patients with schizophrenia receive after stabilization with paliperidone palmitate 1-month (PP1M) or 3-month (PP3M).
The sNDA submission is supported by data from a randomized, double-blind phase 3 study (Route 6) that compared the efficacy and safety of PP6M to PP3M in 702 adults with schizophrenia who were previously stabilized on corresponding doses of PP1M or PP3M. The study consisted of 3 phases: a screening phase (up to 28 days), a maintenance phase (1 or 3 months), and a double-blind phase (at least 12 months).
Results showed that at the end of the 12-month period, treatment with PP6M was found to be noninferior to PP3M with regard to preventing relapse (primary end point) in both the intent-to-treat and per-protocol analysis sets. The safety profile of PP6M was consistent with that seen in previous studies of PP1M and PP3M formulations with no new safety signals.
“We designed this unique dosing regimen so people with schizophrenia and their health care 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, LLC. “We look forward to working with the FDA to add a 6-month formulation to our family of paliperidone palmitate products.”
For more information visit janssen.com.
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; November 2, 2020.