J&J seeks FDA approval for SPRAVATO® as first monotherapy for treatment-resistant depression

Johnson & Johnson has announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the approval of SPRAVATO® (esketamine) CIII nasal spray as a monotherapy for adults suffering from treatment-resistant depression (TRD). This follows over a decade of research and five years of real-world usage, highlighting the safety and efficacy of SPRAVATO®.

Treatment-resistant depression affects nearly 30% of the estimated 280 million people globally living with major depressive disorder (MDD). TRD is characterized by the failure to respond adequately to at least two different oral antidepressants during the same depressive episode. Bill Martin, PhD, Global Therapeutic Area Head, Neuroscience at Johnson & Johnson Innovative Medicine, emphasized the importance of offering effective treatment options for these patients, who often endure prolonged periods of inadequate treatment, leading to significant functional and emotional challenges.

The sNDA submission is backed by positive outcomes from the Phase 4 TRD4005 study. This study assessed the efficacy, safety, and tolerability of SPRAVATO® when used as a standalone treatment. The randomized, double-blind, multicenter, placebo-controlled study demonstrated a rapid improvement in depressive symptoms, with changes in the Montgomery-Asberg Depression Rating Scale (MADRS) observable as early as 24 hours after the first dose and sustained for at least four weeks of treatment. The safety profile of SPRAVATO® monotherapy was consistent with existing clinical data, and no new safety concerns were identified.

Currently, SPRAVATO® is approved by the FDA in conjunction with an oral antidepressant for treating adults with TRD and depressive symptoms in adults with MDD experiencing acute suicidal ideation or behavior. To date, SPRAVATO® has received approval in 77 countries and has been administered to over 100,000 individuals worldwide.

Important Safety Information

SPRAVATO® (esketamine) CIII nasal spray is a prescription medicine used alongside an oral antidepressant to treat adults with TRD and depressive symptoms in adults with MDD who have suicidal thoughts or actions. SPRAVATO® is not intended for use as an anesthetic and its safety and effectiveness for preventing or reducing suicidal thoughts or actions, or in children, have not been established.

Patients should not use SPRAVATO® if they have blood vessel diseases, abnormal connections between veins and arteries, a history of bleeding in the brain, or allergies to esketamine, ketamine, or other ingredients in SPRAVATO®. Before starting SPRAVATO®, patients should inform their healthcare provider of any heart, brain, or liver problems, history of psychosis, or if they are pregnant or planning to become pregnant, as SPRAVATO® may harm the baby.

Patients should discuss all their medications with their healthcare provider, especially central nervous system depressants, psychostimulants, or monoamine oxidase inhibitors, as these can lead to side effects. SPRAVATO® is self-administered under healthcare supervision in a medical setting. After each use, patients will be monitored until they are ready to leave. It is important to have someone to drive them home.

Common side effects include nausea and vomiting, which usually occur right after taking SPRAVATO® and resolve the same day. Patients should avoid eating at least 2 hours before and drinking liquids at least 30 minutes before taking SPRAVATO®. After taking SPRAVATO®, patients should avoid driving or operating machinery until the next day following a restful sleep.

Possible serious side effects include increased blood pressure, problems with thinking clearly, and bladder issues. 

Johnson & Johnson is committed to advancing healthcare innovation to prevent, treat, and cure complex diseases, making treatments smarter and less invasive, and personalizing healthcare solutions.

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