This photo provided by Janssen Global Services shows Spravo nasal spray.
Janssen Global Services (AP)
The U.S. Food and Drug Administration approved Tuesday Johnson & Johnsonof nasal spray Use alone Adults with major depressive disorder that is difficult to treat as drug sales grow.
The spray, called Spravo, is now the first-ever stand-alone treatment for treatment-resistant depression, a condition in which trying at least two standard treatments has had little effect on improving a patient’s depressive symptoms.
Spravo was previously approved in the U.S. for use with oral antidepressants to treat treatment-resistant depression and major depressive disorder in patients who are experiencing thoughts of: suicide or injury. The drug first entered the U.S. market in 2019.
“We want to recognize that this is a drug to treat depression, which can be fatal if left untreated,” Bill Martin, global neuroscience therapeutic area leader for Johnson & Johnson, said in an interview.
Some say that about one-third of the estimated 21 million U.S. adults with major depression are struggling with symptoms that don’t respond to treatment (such as persistent feelings of sadness, sleep disturbances, low energy, and thoughts of death or suicide). Fight. estimate.
“For the first time, we now have a choice that gives patients freedom of choice,” said Dr. Gregory Mattingly, a physician involved in Spravato’s original clinical trial and chairman of the Midwest Research Group.
His center in St. Louis, Missouri, has treated more than 6,000 patients with the drug, and just over 100 people are currently taking it there. The center is one of 3,000 outpatient treatment centers in the United States certified to use Spravo, according to Johnson & Johnson.
Mattingly said patients now have the option of taking Spravo with or without oral antidepressants, especially if those drugs don’t improve symptoms and cause unwanted side effects, such as weight gain and sexual problems.
Johnson & Johnson’s Martin said the approval “provides caregivers and their patients with a path to truly optimize and personalize each individual’s treatment model” and determine the best way for them to manage their disease.
Martin said this could “increase the number of patients who could benefit from Spravo.”
Spravo is becoming a blockbuster product, introducing $780 million According to Johnson & Johnson’s third-quarter earnings report, sales will grow in the first nine months of 2024 as doctors become more accustomed to using it. The company has higher expectations for its own growth, tell investors In December, sales were expected to rise to $1 billion to $5 billion annually.
That’s a boon for J&J as it prepares for upcoming patent expirations and new price negotiations with Medicare to pressure sales of its best-selling inflammation treatment Stelara.
This approval is based on Phase 4 Trialwhich shows that only Spravoto improved Depressive symptoms begin approximately 24 hours after treatment and last for at least a month. The company said the safety profile was consistent with previous clinical data using Spravo in combination with oral antidepressants.
Martin said this shows that when patients take Spravo alone, they get “not just rapid relief, but long-lasting relief.”
Spravo has a long road to rapid growth
Spravo blazed a new trail in 2019, becoming the first new FDA-approved treatment for major depression in more than three decades. The drug is related to ketamine, a common anesthetic with hallucinogenic properties that is sometimes misused for recreational use. Johnson & Johnson makes it a nasal spray so it can reach the brain quickly.
Spravo “turns on neural networks in a different way,” Mattingly said.
“With our standard oral antidepressants, it takes weeks to months to see if they are effective,” he added. “A lot of times, on the same day, the second day, the third day, people already start feeling better after taking Spravo.”
Spravo’s warning label warns of the risks of sedation and dissociation, respiratory depression, suicidal thoughts, drug abuse or misuse, and other potential side effects. Therefore, Spravato is only available through a restricted program, which means it cannot be purchased in pharmacies and can only be used under strict supervision in certified medical facilities.
Healthcare professionals must also monitor drug users for two hours after administration.
Spravo’s launch has gotten off to a slow start, especially as pandemic-related challenges have complicated arrangements for the necessary medical oversight of the drug. But as in-person visits became the norm again, Johnson & Johnson stepped up its efforts to market Spravo, and doctors became more aware of its benefits.
“The mental health community wasn’t used to doing surgery at that time. We weren’t used to holding space. We weren’t used to thinking about how to do Spravo,” Mattingly said. “I think the good news is that now we’re all seeing the benefits it brings to patients. Many of us have become really strong advocates for it.”
Johnson & Johnson’s Martin said five years of real-world data on the drug and a head-to-head study proving Spravo’s superior efficacy over oral antidepressants also give doctors more confidence in the treatment.
