Phase 4 SPRAVATO® monotherapy data shows rapid improvement in depressive symptoms at ~24 hours, sustained through at least 4 weeks
Monotherapy submission builds on more than a decade of research, 31 clinical trials and more than five years of real-world use that reinforce the safety and efficacy of SPRAVATO®
TITUSVILLE, NJ, USA I July 22, 2024 I Johnson & Johnson (NYSE: JNJ) announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of SPRAVATO® (esketamine) CIII nasal spray as a monotherapy for adults living with treatment-resistant depression (TRD). Nearly 30 percent of the estimated 280 million people worldwide living with major depressive disorder (MDD) have TRD,1 which occurs when there is an inadequate response to two or more oral antidepressants during the same depressive episode.
“Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones,” said Bill Martin, PhD, Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine. “We’re pleased to build on the more than a decade of research reinforcing the safety and efficacy of SPRAVATO® and look forward to working with the FDA to bring this innovative treatment to patients as a monotherapy option.”
The submission is supported by positive results from the Phase 4 TRD4005 study that evaluated the efficacy, safety and tolerability of SPRAVATO® administered as a monotherapy. The randomized, double-blind, multicenter, placebo-controlled study showed a rapid change in Montgomery-Asberg Depression Rating Scale (MADRS) total score as early as 24 hours after the first SPRAVATO® dose and sustained through at least 4 weeks of treatment. The safety profile of SPRAVATO® monotherapy was consistent with the existing body of clinical data in combination with an oral antidepressant, and no new safety concerns were identified.2
SPRAVATO® is approved by the FDA, in combination with an oral antidepressant, to treat adults with TRD and depressive symptoms in adults with MDD with acute suicidal ideation or behavior. To date, SPRAVATO® has been approved in 77 countries and administered to more than 100,000 people worldwide.
ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and where solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at http://www.jnj.com or at www.janssen.com/johnson-johnson-innovative-medicine. Follow us at @JNJInnovMed.
Janssen Research & Development, LLC and Janssen Biotech, Inc. are both Johnson & Johnson companies.
- Zhdanava M, Pilon D, Ghelerter I, et al. The prevalence and national burden of treatment-resistant depression and major depressive disorder in the United States. J Clin Psychiatry. 2021;82(2):20m13699.
- A. Janik, X. Qiu, R. Lane, V. Popova, W.C. Drevets, C. Canuso, D.J. Fu. SPRAVATO (Esketamine Nasal Spray) as a Monotherapy for Treatment-resistant Depression (TRD). American Society of Psychopharmacology Annual Meeting.; May 28-31, 2024. Poster W80.
SOURCE: Johnson & Johnson
Post Views: 4,470
Phase 4 SPRAVATO® monotherapy data shows rapid improvement in depressive symptoms at ~24 hours, sustained through at least 4 weeks
Monotherapy submission builds on more than a decade of research, 31 clinical trials and more than five years of real-world use that reinforce the safety and efficacy of SPRAVATO®
TITUSVILLE, NJ, USA I July 22, 2024 I Johnson & Johnson (NYSE: JNJ) announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of SPRAVATO® (esketamine) CIII nasal spray as a monotherapy for adults living with treatment-resistant depression (TRD). Nearly 30 percent of the estimated 280 million people worldwide living with major depressive disorder (MDD) have TRD,1 which occurs when there is an inadequate response to two or more oral antidepressants during the same depressive episode.
“Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones,” said Bill Martin, PhD, Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine. “We’re pleased to build on the more than a decade of research reinforcing the safety and efficacy of SPRAVATO® and look forward to working with the FDA to bring this innovative treatment to patients as a monotherapy option.”
The submission is supported by positive results from the Phase 4 TRD4005 study that evaluated the efficacy, safety and tolerability of SPRAVATO® administered as a monotherapy. The randomized, double-blind, multicenter, placebo-controlled study showed a rapid change in Montgomery-Asberg Depression Rating Scale (MADRS) total score as early as 24 hours after the first SPRAVATO® dose and sustained through at least 4 weeks of treatment. The safety profile of SPRAVATO® monotherapy was consistent with the existing body of clinical data in combination with an oral antidepressant, and no new safety concerns were identified.2
SPRAVATO® is approved by the FDA, in combination with an oral antidepressant, to treat adults with TRD and depressive symptoms in adults with MDD with acute suicidal ideation or behavior. To date, SPRAVATO® has been approved in 77 countries and administered to more than 100,000 people worldwide.
ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and where solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at http://www.jnj.com or at www.janssen.com/johnson-johnson-innovative-medicine. Follow us at @JNJInnovMed.
Janssen Research & Development, LLC and Janssen Biotech, Inc. are both Johnson & Johnson companies.
- Zhdanava M, Pilon D, Ghelerter I, et al. The prevalence and national burden of treatment-resistant depression and major depressive disorder in the United States. J Clin Psychiatry. 2021;82(2):20m13699.
- A. Janik, X. Qiu, R. Lane, V. Popova, W.C. Drevets, C. Canuso, D.J. Fu. SPRAVATO (Esketamine Nasal Spray) as a Monotherapy for Treatment-resistant Depression (TRD). American Society of Psychopharmacology Annual Meeting.; May 28-31, 2024. Poster W80.
SOURCE: Johnson & Johnson
Post Views: 4,470
