Johnson & Johnson (NYSE: JNJ) announced today that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for SPRAVATO® (esketamine) CIII nasal spray as a monotherapy for adults with treatment-resistant depression (TRD). Approximately 30% of the 280 million people globally with major depressive disorder (MDD) suffer from TRD, which is defined as an inadequate response to two or more oral antidepressants during the same depressive episode.
“Many patients with challenging-to-treat depression cycle through multiple treatments without effectively resolving their symptoms, imposing a significant 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 over 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.”
Positive Phase 4 Study Results
The sNDA is supported by positive results from the Phase 4 TRD4005 study, which evaluated the efficacy, safety, and tolerability of SPRAVATO® administered as a monotherapy. The randomized, double-blind, multicenter, placebo-controlled study demonstrated a rapid change in Montgomery-Asberg Depression Rating Scale (MADRS) total score as early as 24 hours after the first SPRAVATO® dose, with effects sustained through at least four weeks of treatment.
The safety profile of SPRAVATO® monotherapy was consistent with existing data when combined with an oral antidepressant, with no new safety concerns identified. SPRAVATO® is already FDA-approved in combination with an oral antidepressant to treat adults with TRD and depressive symptoms in adults with MDD with acute suicidal ideation or behavior. Currently approved in 77 countries, SPRAVATO® has been administered to more than 100,000 people worldwide.
What is SPRAVATO® (esketamine) CIII nasal spray?
SPRAVATO® is a prescription medicine used with an oral antidepressant to treat Adults with treatment-resistant depression (TRD), Depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions, SPRAVATO® is not approved for use as an anesthetic. Its safety and effectiveness in preventing suicide or in children are not known. SPRAVATO® can cause serious side effects, including sedation and dissociation, respiratory depression, and increased risk of abuse and misuse. Patients must be monitored for at least two hours after administration. The drug is available only through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program.
SPRAVATO® can also increase the risk of suicidal thoughts and actions in people 24 years of age and younger. Patients and their families should be vigilant for any sudden changes in mood or behavior and report these to their healthcare provider immediately. Patients will self-administer SPRAVATO® under healthcare provider supervision in a certified healthcare setting. They must follow the treatment schedule exactly and plan for a caregiver or family member to drive them home after treatment.
Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of SPRAVATO®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc., and/or Johnson & Johnson.
Risks and uncertainties include, but are not limited to challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products, and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of healthcare products and services; changes to applicable laws and regulations, including global healthcare reforms; and trends toward healthcare cost containment.
Resource: Johnson & Johnson, July 22, 2024
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