This photo provided by Janssen Global Services shows Spravato nasal spray.
Janssen Global Services via AP
The Food and Drug Administration approved it on Tuesday. johnson & johnsonnasal spray Use alone As drug sales increase, more adults are suffering from difficult-to-treat major depressive disorder.
The spray, called Spravato, is the first-ever monotherapy for treatment-resistant depression. Treatment-resistant depression is when at least two standard treatments have had little effect on improving a patient’s depression symptoms.
Previously, Spravato was approved in the United States for use in combination with oral antidepressants for both treatment-resistant depression and patients with major depressive disorder who experience thoughts of: Ta. suicide or harm. The drug first entered the U.S. market in 2019.
“We want to recognize that this is a medicine that treats a disease. [when] If left untreated, depression can be potentially fatal,” Bill Martin, J&J’s global therapeutic area head of neuroscience, said in an interview.
According to some researchers, about one-third of the estimated 21 million U.S. adults with severe depression do not respond to treatment, resulting in persistent feelings of sadness, sleep disturbances, and decreased energy. , who is battling symptoms such as thoughts of death and suicide. estimate.
“For the first time in history, we have a choice that gives patients freedom,” said Dr. Gregory Mattingly, an internist and president of the Midwest Research Group who worked on Spravat’s initial clinical trials.
His center in St. Louis, Missouri, has treated more than 6,000 patients with the drug, with just over 100 currently taking it. It is one of 3,000 outpatient treatment centers in the United States certified to administer Spravat, according to J&J’s tally.
Mattingly said patients can now take Spravat with or without oral antidepressants, especially if oral antidepressants do not improve symptoms and cause undesirable side effects such as weight gain or sexual problems. He said he could choose to take it.
J&J’s Martin said the approval provides a means for “caregivers and patients to optimize and personalize treatment paradigms for each individual” and determine the best way to manage the disease.
This could potentially “increase the number of patients who benefit” from Spravato, Martin said.
Spravato is on its way to becoming a blockbuster, and the drug is $780 million J&J’s third-quarter earnings show sales increased in the first nine months of 2024 as doctors became more comfortable using the company. There are high expectations for the company’s growth. tell investors The company announced in December that it expects sales to increase from $1 billion to $5 billion annually.
This is a boon for J&J, which is bracing for upcoming patent expirations and new price negotiations with Medicare for its top-selling inflammation drug Stelara.
Approval is Phase 4 studyThe study showed that Spravato alone improved symptoms of depression, starting about 24 hours after treatment and lasting for at least a month. The company said the safety profile is consistent with previous clinical data regarding the use of Supravat in combination with oral antidepressants.
Martin said patients have demonstrated “not just rapid symptom relief, but sustained symptom relief” when they take Supravat alone.
Spravato’s long road to rapid growth
Spravato broke new ground in 2019 as the first new major depression treatment to win FDA approval in more than 30 years. The drug is related to ketamine, a common anesthetic that can cause hallucinogenic effects and is sometimes misused for recreational purposes. J&J has made it into a nasal spray to quickly penetrate the brain.
Spravato “enables neural networks in a different way,” Mattingly said.
“Our standard oral antidepressants took weeks to months to see if they were effective,” he added. With Spravato, “you’ll often already start feeling somewhat better the same day, the next day, and the day after that.”
Spravato’s warning label warns of the risk of sedation and dissociation, respiratory depression, suicidal ideation, and drug abuse or misuse, among other potential side effects. Therefore, Spravato is only available through limited programs. This means that it cannot be purchased in pharmacies and is only administered in certified medical settings under strict supervision.
Users of this drug must also be monitored by a health care professional for two hours after administration.
Supravat’s launch got off to a slow start, especially as pandemic-related challenges complicated the medical oversight arrangements needed for the drug. But after in-person doctor visits became the norm again and doctors became more aware of its benefits, J&J began promoting Spravato more heavily.
“At that time, the mental health community wasn’t really used to doing procedures. We weren’t used to having space. We weren’t used to thinking about how to do spravato,” Mattingly said. he said. “I think the good news is that we all now recognize the benefits for patients. 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 direct studies demonstrating Supravat’s superior effectiveness over oral antidepressants give doctors more confidence in the treatment. It was completed.
