Janssen Pharmaceuticals, Inc.

Janssen Pharmaceutica Nv

Srihari Gopal

Adam Savitz

Wayne C Drevets

Vanina Popova

Rama Melkote

Mark Schmidt

Darrel Pemberton

Chakradhar Lagishetty

Iva Kezic

Huybrecht T'Jollyn

Raja Venkatasubramanian

Philippe Fernandes

John Louie

Vaibhav Narayan

Alfons Jeanne Wouters

Panna Sanga

Ruth Milz

Geert Van Der Avoort

Nicolaas Martha Felix Goyvaerts

Dean Najarian

Mahesh N Samtani

Frank Meeussen

Jimmy Nguyen

Steven Wang

Ignace Wallaert

Peter D'Hoore

Dai Wang

Paulien Gerarda Maria Ravenstijn

Susan Baker

Alberto Russu

Matthieu Ravelingien

Katarina Jokicevic

Mahesh Narain Samtani

Laura Martinez Marcos

Tom Huybrechts

Tatiana Marcozzi

An Margriet Vermeulen

Vivek Kusumakar

Peter H Lewyn-Briscoe

Mahesh Samtani

Paulien Gerada Ravenstijn

Peter D'HOORE

The present invention provides methods of treating patients with long acting injectable paliperidone palmitate formulations. The disclosure includes methods for mitigating at least one adverse change in blood lipid levels of a patient in need thereof who has been treated with a paliperidone palmitate extended-release injectable suspension at either one-month intervals (PP1M) or three-month intervals (PP3M), comprising transitioning the patient to a paliperidone palmitate extended-release injectable suspension having a six month dosing interval (PP6M).

Dosing regimens associated with extended release paliperidone injectable formulations

The disclosure provides methods for treating major depressive disorder in a human patient having moderate or severe anhedonia. The methods comprise administering to the patient in need thereof an effective amount of aticaprant, or a pharmaceutically acceptable salt thereof. In some embodiments, the patient had an inadequate response to other antidepressant therapy prior to treatment with aticaprant. In other embodiments, the other antidepressant therapy comprised a selective serotonin reuptake inhibitor (SSRI), serotonin-norepinephrine reuptake inhibitor (SNRI), or a combination thereof.

Compositions and methods for the treatment of depression

The present invention provides a method of treating patients with long acting injectable paliperidone palmitate formulations.

The present disclosure relates to compositions, including oral compositions in the form of tablets, comprising aticaprant and methods of using the same.

Compositions comprising aticaprant

The disclosure provides crystalline and amorphous forms of aticaprant. Also provided by the disclosure are pharmaceutical compositions comprising the amorphous or crystalline forms, methods of treating major depressive disorder using the amorphous or crystalline forms of aticaprant, amorphous or crystalline forms of aticaprant for use in the treatment of major depressive disorder in a human patient having anhedonia, uses of the amorphous or crystalline forms of aticaprant in the manufacture of a medicament for the treatment of major depressive disorder, and packages or pharmaceutical products comprising (i) amorphous or crystalline forms of aticaprant and (ii) instructions for treating major depressive disorder. In some aspects, the human patient treated as described herein has anhedonia.

Forms of aticaprant

The invention provides methods of identifying schizophrenia patients at risk for relapse. The invention also provides methods of early detection of schizophrenic relapse. The disclosed methods use monitoring of a subset of symptoms and/or one or more biomarkers. The symptom severity can be assessed using the Positive and Negative Syndrome Scale (PANSS) parameters. The methods of the invention can be used to provide early intervention to decrease or prevent relapse in schizophrenia patients.

Methods of identifying schizophrenia patients at risk for relapse

Provided are methods for improving resuspendability of a paliperidone palmitate extended-release injectable suspension within a syringe, for reducing a force required for injection of a paliperidone palmitate extended-release injectable suspension, or for reducing the likelihood of incomplete injection of a paliperidone palmitate extended-release injectable suspension comprising maintaining the syringe in a desired orientation during shipping of the syringe that varies from the orientation of the syringe during pre-shipping storage. Also provided are populations of syringes that respectively contain paliperidone palmitate extended release injectable suspension, wherein each of the syringes have been shipped to a destination, and the syringes were each maintained in a desired orientation during shipping of the syringe that varies from the orientation of the syringe during pre-shipping storage. The present disclosure also provides pharmaceutical products comprising a paliperidone palmitate extended-release injectable suspension within a syringe for administration to a patient suffering from schizophrenia, wherein the syringe has undergone pre-shipping storage and has been shipped, and wherein the syringe has been maintained in an orientation during the shipping that varies from the orientation of the syringe during pre-shipping storage.

Methods for ensuring resuspension of paliperidone palmitate formulations

The present application provides a method for treating patients in need of psychiatric treatment, wherein said patient is being treated with the 3-month formulation of paliperidone palmitate and fails to take the next scheduled dose of the 3-month formulation of paliperidone palmitate.

Dosing regimen for missed doses for long-acting injectable paliperidone esters

Growing community of inventors

Belle Mead, NJ, United States of America

Srihari Gopal