FDA Approves Spravato Nasal Spray as a Standalone Treatment for Major Depressive Disorder

The FDA approved Spravato (esketamine) CIII nasal spray today as a first-of-its-kind, standalone treatment for adults with major depressive disorder (MDD) who haven't responded well to at least two oral antidepressants.

MDD is one of the most common mental health disorders, affecting about 21 million adults in the U.S.

However, one-third of folks with the disorder experience treatment-resistant depression (TRD), a condition that makes it more difficult to be treated by traditional oral antidepressants, according to a press release by Johnson & Johnson.

This approval comes after a Priority Review, which indicates that the FDA sees this treatment as highly needed.

It is also based on results from a randomized, double-blind, multicenter, placebo-controlled study, where those who used Spravato alone showed faster and more significant improvements in their depression scores compared to those who took a placebo.

After 4 weeks, 22.5% of patients on Spravato achieved remission and received a much lower depression score, compared to just 7.6% of those on the placebo.

Bill Martin, Ph.D., global therapeutic area head at Johnson & Johnson, said that patients who take Spravato may experience improvements in depressive symptoms as early as 24 hours and at 28 days – without the need for daily oral antidepressants.

The drug works by targeting glutamate, a common neurotransmitter in the brain. While the exact way it works is still not fully understood, studies have shown that it can help reduce depression symptoms quickly.

Spravato has been used for years in combination with other antidepressants, and over 140,000 patients worldwide have been treated with it.

A representative from Johnson & Johnson explained that the cost of Spravato for patients depends on their insurance and how their healthcare plan is structured.

“We have worked hard to demonstrate the clinical value of Spravato which has helped drive strong access for patients, but again patients’ out-of-pocket costs are determined by insurance benefit design,” the representative said.

They also noted that reimbursement for the two-hour monitoring period required during treatment depends on the specific agreement’s clinics have with insurance companies.

The representative did not share the drug’s current market value, but according to the National Institutes of Health, it’s at a value of $18,564 to $45,591 in the first year and about $14,196 to $42,588 by the second and on.

Spravato has a safety profile that is similar with its previous use though there are some risks, including sedation, dissociation, respiratory depression and potential for misuse.

Because of these risks, Spravato is only available through a restricted program known as the Spravato Risk Evaluation and Mitigation Strategy (REMS) Program, which ensures it is used safely.

Gregory Mattingly, M.D., president of midwest research Group, said in the press release that “For more than six years, I've seen firsthand the real-world impact Spravato can have on patients' lives. 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.”

While Spravato has already helped many with treatment-resistant depression, there are calls for more research on its potential use in younger patients.

Depression among younger patients has been increasing, especially after the COVID-19 pandemic.

According to a previous report by MHE, in 2021, nearly 20.1% of U.S. young adults aged 12 to 17 reported experiencing at least one major depressive episode.

Advocates are urging more studies to explore whether Spravato could help this younger group.

Although research is still ongoing regarding the drug’s use in younger patients, its potential to help adults with treatment-resistant depression is already a significant breakthrough.