Johnson & Johnson Submits Supplemental New Drug Application to FDA for Spravato as Monotherapy for Adults with Treatment-Resistant Depression

Image Credit: Adobe Stock Images/Sergey Nivens

Johnson & Johnson (J&J) has submitted a supplemental New Drug Application (sNDA) to the FDA for the approval of Spravato (esketamine) as the first and only monotherapy for the treatment of treatment-resistant depression (TRD). According to the company, the sDNA is supported by encouraging data from the Phase IV TRD4005 trial, which evaluated the efficacy, safety, and tolerability of Spravato as a monotherapy.¹

“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, in a press release. “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 randomized, double-blind, multicenter, placebo-controlled TRD4005 trial demonstrated the rapid and sustained efficacy of Spravato, with some responses beginning as early as 24 hours after the first dose based on the Montgomery-Asberg Depression Rating Scale total score. Additionally, the treatment was sustained after at least four weeks.

No new safety signals were reported during the study. Common adverse events associated with Spravato include dizziness, nausea, drowsiness, a spinning sensation, numbness, anxiety, lack of energy, increased blood pressure, vomiting, feeling intoxicated, or feeling disconnected from reality, and increased feelings of happiness or excitement. It can also result in a temporary increase in blood pressure, cause problems with thinking clearly, and frequent bladder issues.¹

According to John Hopkins Medicine, TRD affects approximately 30% of people diagnosed with major depressive disorder. Further, data from the Centers for Disease Control and Prevention suggests that teen suicide rates are on the rise as a result.2 Currently, TRD is more common in women, with a 2:6 ratio to men. Other statistics include:

• A higher medical cost due to comorbidities and underlying conditions.
• 37% of patients with TRD also resist current TRD treatments.
• TRD is common in individuals with bipolar disorder, accounting for 30% of bipolar patients during depressive phases.³

“Depressive disorder often first appears among people in their late teens to early 20s,” said Jennifer Coughlin, MD, co-founder, co-director, John Hopkins’ Brain Health Program, in an article published by John Hopkins Medicine. “Finding effective depression treatment in youth and young adults is critical when young people are making decisions and developing habits and coping mechanisms that can affect their lives’ trajectories and preparations for their futures.”

J&J warns against the use of Spravato in patients who have blood vessel (aneurysmal vascular) disease, an abnormal connection between the veins and arteries (arteriovenous malformation), a history of brain bleeding, or allergies to ingredients such as ketamine or esketamine. Additionally, patients should contact their healthcare provider before taking Spravato if they have ever had liver problems, psychosis, are currently or plan on becoming pregnant, or are currently breastfeeding. Patients should not do anything that requires full attention after taking Spravato for at least a full day of rest.

Currently, 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. At this time, it is unknown whether the treatment if effective in pediatric patients.¹

References

1. Johnson & Johnson seeks U.S. FDA approval of SPRAVATO® (esketamine) as the first and only monotherapy for adults with treatment-resistant depression. J&J. July 22, 2024. Accessed July 22, 2024. https://www.jnj.com/media-center/press-releases/johnson-johnson-seeks-u-s-fda-approval-of-spravato-esketamine-as-the-first-and-only-monotherapy-for-adults-with-treatment-resistant-depression 

2. Treatment-Resistant Depression. John Hopkins Medicine. Accessed July 22, 2024. https://www.hopkinsmedicine.org/health/conditions-and-diseases/mood-disorders/treatment-resistant-depression

3. Top 5 Treatment-Resistant Depression Statistics You Need to Know. Brain Therapy TMS. May 28, 2021. Accessed July 22, 2024. https://braintherapytms.com/top-5-treatment-resistant-depression-statistics/