This photo provided by Janssen Global Services shows Spravato nasal spray.
Janssen Global Services via AP
The Food and Drug Administration approved Tuesday Johnson & JohnsonThe nasal spray is for use alone in adults with difficult-to-treat major depressive disorder, as sales of the drug increase.
The spray, called Spravato, is now the first-ever standalone treatment for treatment-resistant depression, meaning trying two or more standard treatments does little or nothing to improve symptoms of depression. depression in a patient.
Previously, Spravato had been approved in the United States for use with an oral antidepressant both for treatment-resistant depression and for people with major depressive disorder who have suicidal thoughts or harm. The drug first entered the US market in 2019.
“We want to recognize that this is a drug that treats a disease that, if left untreated, depression is potentially life-threatening,” said Bill Martin, global head of neuroscience therapeutic area at J&J, in an interview.
By some estimates, about a third of the 21 million U.S. adults with major depression struggle with symptoms—such as persistent feelings of sadness, trouble sleeping, low energy, and thoughts of death or suicide—that do not respond to treatment.
“For the first time ever, we now have an option that gives patients freedom,” said Dr. Gregory Mattingly, a physician and president of Midwest Research Group who participated in Spravato’s early clinical trials.
Its center in St. Louis, Missouri, has treated more than 6,000 patients with the drug, and currently just over 100 people there are taking the drug. It is one of 3,000 outpatient treatment centers in the United States certified to administer Spravato, by J&J’s count.
Mattingly said patients can now choose to take Spravato with or without an oral antidepressant, especially if those pills don’t improve their symptoms and cause unwanted side effects, such as weight gain and sexual problems.
J&J’s Martin said the approval provides “an avenue for caregivers and their patients to truly optimize, personalize the treatment paradigm for each individual” and determine the best way for them to manage the disease.
This could potentially “increase the number of patients who could benefit” from Spravato, according to Martin.
Spravato is poised to become a blockbuster product, with the drug generating $780 million in sales in the first nine months of 2024, as doctors become more comfortable with its use, according to results from the J&J’s third quarter. The company has even higher expectations for its growth, telling investors in December that it expects sales to increase between $1 billion and $5 billion annually.
It’s a boon for J&J as it prepares for an upcoming patent expiration and new prices negotiated with Medicare to pressure sales of its top-selling inflammatory treatment, Stelara.
The approval is based on a phase four trial, which showed that Spravato alone improved depressive symptoms beginning approximately 24 hours after treatment and lasting at least one month. The company said the safety profile was consistent with previous clinical data on the use of Spravato in combination with oral antidepressants.
Martin said this demonstrates “not only rapid symptom relief, but also lasting symptom relief” when patients take Spravato alone.
Spravato’s long road to rapid growth
Spravato led the way in 2019 as the first new treatment for major depression to gain FDA approval in more than three decades. The drug is related to ketamine, a common anesthetic that can have hallucinogenic effects and is sometimes misused recreationally. J&J made it into a nasal spray to quickly deliver it to the brain.
Spravato “activates neural networks in a different way,” Mattingly said.
“It took weeks, if not months, to see if they would work with our standard oral antidepressants,” he added. “Very often, the same day, the next day, the next day, people can already start to feel like they’re feeling a little bit better” with Spravato.
Spravato’s warning label warns of the risk of sedation and dissociation, respiratory depression, suicidal thoughts, and abuse or misuse of the drug, among other potential side effects. For this reason, Spravato is only available under a restricted program, meaning it cannot be purchased in pharmacies and is only administered in certified health care settings under strict supervision.
Users of the drug should also be monitored by a healthcare professional for two hours after administration.
The launch of Spravato got off to a slow start, especially as pandemic-related challenges complicated arrangements for necessary medical oversight of the drug. But J&J began marketing Spravato more widely after in-person doctor visits became the norm again and doctors became more aware of its benefits.
“The mental health community wasn’t really used to doing procedures at that point. We weren’t used to having a dedicated space. We weren’t used to thinking about how to do Spravato,” Mattingly said. “I think the good news is that now we have all seen the benefits for our patients. Many of us have become very strong advocates” of this project.
Five years of real-world data on the drug and a comparative study demonstrating Spravato’s superior effectiveness compared to an oral antidepressant also gave doctors greater confidence in the treatment, according to J&J’s Martin.
