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2 results on '"Jadwiga Martynowicz"'

1. U.S. Food and Drug Administration’s Patient-Focused Drug Development Initiative: Experience with Integration of Patient-Experience Data in a New Drug Application for Esketamine Nasal Spray Plus a Newly Initiated Oral Antidepressant for Treatment-Resistant Depression

Author

Bennett Levitan, Patricia Treichler, Eva G. Katz, Pauline McNulty, Jadwiga Martynowicz, and Carol Jamieson

Subjects
medicine.medical_specialty, medicine.medical_treatment, Pharmacy, Analytical Report, Esketamine nasal spray, Double-Blind Method, Drug Development, Patient experience, medicine, Humans, Pharmacology (medical), Patient preference, Prescription Drug User Fee Act, Pharmacology, Toxicology and Pharmaceutics (miscellaneous), New drug application, Patient-reported outcomes, Depression, United States Food and Drug Administration, business.industry, Public Health, Environmental and Occupational Health, Patient-Focused Drug Development, Nasal Sprays, medicine.disease, Antidepressive Agents, United States, Patient-experience, Patient Health Questionnaire, Nasal spray, Drug development, Family medicine, Ketamine, Treatment-resistant depression, business
Abstract

The Patient-Focused Drug Development initiative of the U.S. Food and Drug Administration (FDA) aims to ensure that the patient experience of disease and treatment is an integral component of the drug development process. The 21st Century Cures Act and Prescription Drug User Fee Act (PDUFA) VI require the FDA to publicly report the type of patient-experience data reviewed in a new drug application (NDA) to inform regulatory decision-making. This report describes a recent approach adopted at Janssen of integrating patient-experience data into the NDA for esketamine (SPRAVATO®) nasal spray with a newly initiated oral antidepressant (esketamine + AD) for treatment-resistant depression. During the development of esketamine + AD, patient-experience data were collected using several patient-reported outcomes, including the Sheehan Disability Scale and 9-item Patient Health Questionnaire (PHQ-9). Additionally, a patient-preference study assessed the relative importance of benefits and harms that patients allocated to different attributes of treatment. Preferences were collected from patients enrolled in phase 3 esketamine trials and from an online panel of primarily ketamine-naive patients. Patient-experience data were integrated into the esketamine NDA, the FDA advisory committee meeting briefing document, and the Sponsor’s presentation. The FDA acknowledged reviewing the patient-experience data and determined that they supported esketamine + AD for treatment-resistant depression. This report highlights the importance of integrating patient-experience methods early in drug development, their impact on assessing patient-relevant benefits and risks, and how they can help improve clinical program design.

Published
2021

2. A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials

Author

Luca Sforzini, Courtney Worrell, Melisa Kose, Ian M. Anderson, Bruno Aouizerate, Volker Arolt, Michael Bauer, Bernhard T. Baune, Pierre Blier, Anthony J. Cleare, Philip J. Cowen, Timothy G. Dinan, Andrea Fagiolini, I. Nicol Ferrier, Ulrich Hegerl, Andrew D. Krystal, Marion Leboyer, R. Hamish McAllister-Williams, Roger S. McIntyre, Andreas Meyer-Lindenberg, Andrew H. Miller, Charles B. Nemeroff, Claus Normann, David Nutt, Stefano Pallanti, Luca Pani, Brenda W. J. H. Penninx, Alan F. Schatzberg, Richard C. Shelton, Lakshmi N. Yatham, Allan H. Young, Roland Zahn, Georgios Aislaitner, Florence Butlen-Ducuing, Christine Fletcher, Marion Haberkamp, Thomas Laughren, Fanni-Laura Mäntylä, Koen Schruers, Andrew Thomson, Gara Arteaga-Henríquez, Francesco Benedetti, Lucinda Cash-Gibson, Woo Ri Chae, Heidi De Smedt, Stefan M. Gold, Witte J. G. Hoogendijk, Valeria Jordán Mondragón, Eduard Maron, Jadwiga Martynowicz, Elisa Melloni, Christian Otte, Gabriela Perez-Fuentes, Sara Poletti, Mark E. Schmidt, Edwin van de Ketterij, Katherine Woo, Yanina Flossbach, J. Antoni Ramos-Quiroga, Adam J. Savitz, Carmine M. Pariante, Sforzini, L., Worrell, C., Kose, M., Anderson, I. M., Aouizerate, B., Arolt, V., Bauer, M., Baune, B. T., Blier, P., Cleare, A. J., Cowen, P. J., Dinan, T. G., Fagiolini, A., Ferrier, I. N., Hegerl, U., Krystal, A. D., Leboyer, M., McAllister-Williams, R. H., Mcintyre, R. S., Meyer-Lindenberg, A., Miller, A. H., Nemeroff, C. B., Normann, C., Nutt, D., Pallanti, S., Pani, L., Penninx, B. W. J. H., Schatzberg, A. F., Shelton, R. C., Yatham, L. N., Young, A. H., Zahn, R., Aislaitner, G., Butlen-Ducuing, F., Fletcher, C., Haberkamp, M., Laughren, T., Mantyla, F. -L., Schruers, K., Thomson, A., Arteaga-Henriquez, G., Benedetti, F., Cash-Gibson, L., Chae, W. R., De Smedt, H., Gold, S. M., Hoogendijk, W. J. G., Mondragon, V. J., Maron, E., Martynowicz, J., Melloni, E., Otte, C., Perez-Fuentes, G., Poletti, S., Schmidt, M. E., van de Ketterij, E., Woo, K., Flossbach, Y., Ramos-Quiroga, J. A., Savitz, A. J., Pariante, C. M., Institute of Psychiatry, Psychology & Neuroscience, King's College London, King‘s College London, Nutrition et Neurobiologie intégrée (NutriNeuro), Université de Bordeaux (UB)-Institut Polytechnique de Bordeaux-Ecole nationale supérieure de chimie, biologie et physique-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Department of Psychiatry and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität Dresden = Dresden University of Technology (TU Dresden), The Florey Institute of Neuroscience and Mental Health, University of Melbourne, IMRB - 'Neuropsychiatrie translationnelle' [Créteil] (U955 Inserm - UPEC), Institut Mondor de Recherche Biomédicale (IMRB), Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), and European Project: (grant No 116060),IMPRiND

Subjects
Depression, Diagnostic markers, DISORDER, STIMULATION, STAR-ASTERISK-D, SEROTONIN REUPTAKE INHIBITORS, Major Depressive Disorder, Clinical Trials and Supportive Activities, Medical and Health Sciences, Depressive Disorder, Treatment-Resistant, Cellular and Molecular Neuroscience, REPORT QIDS-SR, SDG 3 - Good Health and Well-being, Clinical Research, Humans, RATING-SCALE, Molecular Biology, METAANALYSIS, Psychiatry, Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant, Psychology and Cognitive Sciences, Major, REMISSION, Biological Sciences, Serious Mental Illness, Brain Disorders, Psychiatry and Mental health, QUICK INVENTORY, Mental Health, Good Health and Well Being, SYMPTOMATOLOGY, [SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]
Abstract

Criteria for treatment-resistant depression (TRD) and partially responsive depression (PRD) as subtypes of major depressive disorder (MDD) are not unequivocally defined. In the present document we used a Delphi-method-based consensus approach to define TRD and PRD and to serve as operational criteria for future clinical studies, especially if conducted for regulatory purposes. We reviewed the literature and brought together a group of international experts (including clinicians, academics, researchers, employees of pharmaceutical companies, regulatory bodies representatives, and one person with lived experience) to evaluate the state-of-the-art and main controversies regarding the current classification. We then provided recommendations on how to design clinical trials, and on how to guide research in unmet needs and knowledge gaps. This report will feed into one of the main objectives of the EUropean Patient-cEntric clinicAl tRial pLatforms, Innovative Medicines Initiative (EU-PEARL, IMI) MDD project, to design a protocol for platform trials of new medications for TRD/PRD.

Published
2022

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