FDA Approves Johnson & Johnson’s Spravato for Treatment-Resistant Depression

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The FDA has approved Johnson & Johnson’s (J&J) Spravato (esketamine) CIII nasal spray, marking the first monotherapy to be approved for adults with treatment-resistant depression (TRD). According to the company, approval was supported by a pivotal placebo-controlled study in which Spravato demonstrated rapid and superior improvements in depressive symptoms as early as 24 hours, which were sustained through 28 days.¹

“Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them. For too long, healthcare providers have had few options to offer patients much-needed symptom improvement,” said Bill Martin, PhD, global therapeutic area head, neuroscience, Johnson & Johnson Innovative Medicine. “Spravato is now available as a standalone treatment, meaning patients may experience improvements in depressive symptoms as early as 24 hours and at 28 days, without the need for daily oral antidepressants.”

Results from the pivotal study demonstrated that 22.5% of patients achieved remission from TRD at week four when treated with Spravato compared to 7.6% for placebo based on the Montgomery-Asberg Depression Rating Scale.

The safety profile of Spravato was found to be consistent with prior data, but due to potential adverse events (AEs), such as sedation, dissociation, respiratory depression, abuse, and misuse, the treatment is available only through the Spravato REMS program. Common AEs include temporary increased blood pressure; issues with thinking clearly; bladder problems; nausea; dizziness; drowsiness; numbness; anxiety; lack of energy; headache; increased feelings of happiness or excitement; feeling drunk; and headache.

J&J warns against the use of Spravato in patients who have blood vessel disease, abnormal connections between veins and arteries, history of bleeding in the brain, or are allergic to esketamine, ketamine, or any other treatment ingredients.¹

According to the Anxiety & Depression Association of America (ADAA), major depressive disorder (MDD) is the leading cause of disability for patients between 15 and 44 years of age in the United States. While it can develop at any age, the median age of onset for MDD is 32.5 years or age. Additionally, an estimated 21% of all adults in the United States will experience MDD at some point in their lifetime. Currently, MDD effects an 8.4% of the adult population in the United States and nearly 49% are not receiving medication. It is more prevalent in women than in men.²

“Depression is the leading cause of disability worldwide as measured by Years Lived with Disability. Almost 75% of people with mental disorders remain untreated in developing countries, with almost 1 million people taking their lives each year. In addition, according to the World Health Organization(WHO), one in 13 people globally suffers from anxiety. The WHO reports that anxiety disorders are the most common mental disorders worldwide with specific phobia, major depressive disorder and social phobia being the most common anxiety disorders,” states ADAA.

To date, Spravato has been administered to over 140,000 patients globally.¹

“For more than six years, I’ve seen firsthand the real-world impact Spravato can have on patients’ lives,” said Gregory Mattingly, MD, president, Midwest Research Group, founding partner, St. Charles Psychiatric Associates, in the press release. “Now that it is also available as a monotherapy, healthcare providers have the freedom to further personalize treatment plans based on individual needs, so patients can experience the efficacy of Spravato in as little as 24 hours, through day 28, without the need for a daily oral antidepressant.”

References

1. SPRAVATO^® (esketamine) approved in the U.S. as the first and only monotherapy for adults with treatment-resistant depression. J&J. January 21, 2025. Accessed January 21, 2025. https://www.jnj.com/media-center/press-releases/spravato-esketamine-approved-in-the-u-s-as-the-first-and-only-monotherapy-for-adults-with-treatment-resistant-depression

2. Depression Facts & Statistics. ADAA. Accessed January 21, 2025. https://adaa.org/understanding-anxiety/depression/facts-statistics#:~:text=Major%20Depressive%20Disorder%20(MDD)&text=MDD%20affects%20more%20than%2021,in%20women%20than%20in%20men.