This photo provided by Janssen Global Services shows Spravato nasal spray.
Janssen Global Services via AP
The Food and Drug Administration gave approval Tuesday Johnson & JohnsonAs sales of the drug increase, Dr.
The spray, called Spravato, is now the first stand-alone therapy for treatment-resistant depression, i.e.
Previously, Spravato was approved in the U.S. for use with an oral antidepressant in both treatment-resistant depression and in people with major depressive disorder who are thinking about suicide or harm. The drug first came onto the US market in 2019.
“We want to recognize that this is a medicine that treats a disease [when] “Untreated, depression is potentially fatal,” Bill Martin, head of neuroscience for J&J’s global therapeutics division, said in an interview.
About a third of the estimated 21 million U.S. adults with major depression, by some estimates, struggle with symptoms — such as persistent feelings of sadness, trouble sleeping, lack of 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 was involved in Spravato's original clinical trials.
Its St. Louis center has treated more than 6,000 patients with the drug, and just over 100 people there are currently taking it. This is one of 3,000 outpatient treatment centers in the U.S. certified to administer Spravato, according to J&J's tally.
Mattingly said patients can now choose to take Spravato with or without an oral antidepressant, especially if those pills do not improve their symptoms and cause unwanted side effects such as weight gain and sexual problems.
J&J's Martin said the approval “provides caregivers and their patients the opportunity to truly optimize and personalize the treatment paradigm for each individual” and determine the best way for them to manage the disease.
According to Martin, this could potentially “increase the number of patients who could benefit from Spravato.”
More CNBC Health coverage
Spravato is on track to become a blockbuster product, with the drug bringing in $780 million in sales in the first nine months of 2024, as doctors become more comfortable with its use, according to J&J's results for the third quarter. The company has even higher growth expectations, telling investors in December that it expects revenue to rise to between $1 billion and $5 billion a year.
That's a boon for J&J as it prepares for an impending patent expiration and new prices negotiated with Medicare to pressure sales of its top-selling inflammation drug Stelara.
The approval is based on a Phase 4 study that showed Spravato alone improved depressive symptoms starting about 24 hours after treatment and lasting at least a month. The company said the safety profile was consistent with previous clinical data using Spravato in combination with oral antidepressants.
Martin said that taking Spravato alone showed “not only rapid symptom relief, but also lasting symptom relief.”
Spravato's long road to rapid growth
Spravato paved the way in 2019 as the first new drug to treat major depression to receive FDA approval in more than three decades. The drug is related to ketamine, a common anesthetic that can have hallucinogenic effects and is sometimes abused recreationally. J&J turned it into a nasal spray to deliver it quickly to the brain.
Spravato “activates neural networks in a different way,” Mattingly said.
“It took weeks to months for our standard oral antidepressants to take effect,” he added. “People often notice on the same day that they feel a little better the next day,” says Spravato.
Spravato's warning warns of the risk of sedation and dissociation, respiratory depression, suicidal ideation, and misuse or misuse of the drug, among other possible side effects. For this reason, Spravato is only available through a restricted program, meaning it cannot be purchased in a pharmacy and is only administered in certified healthcare facilities under strict supervision.
Users of the medication must also be monitored by a healthcare professional for two hours after administration.
Spravato's launch got off to a slow start, particularly as pandemic-related challenges complicated arrangements for the drug's necessary medical monitoring. However, J&J began marketing Spravato more heavily after in-person doctor visits became the norm again and doctors became more aware of its benefits.
“At that point, the mental health community wasn’t really used to doing interventions. “I think the good news is that we have all now seen the benefits for our patients. So many of us have become really strong advocates” for it.
J&J's Martin said five years of real-world data on the drug and a comparative study demonstrating Spravato's superior effectiveness to an oral antidepressant have also increased doctors' confidence in the treatment.
If you are having suicidal thoughts or are in distress, contact the Suicide and crisis lifeline on 988 for support and assistance from a trained counselor.
