FDA Approves Johnson & Johnson’s Nasal Spray for Depression
The First-Ever Standalone Therapy for Treatment-Resistant Depression
The Food and Drug Administration (FDA) has approved Johnson & Johnson’s nasal spray, Spravato, to be used alone in adults with a major depressive disorder that is difficult to treat, as sales of the drug grow.
Spravato is now the first-ever standalone therapy for treatment-resistant depression, which is when trying at least two standard treatments does little to nothing to improve depression symptoms in a patient.
A New Option for Patients
Previously, Spravato was cleared in the U.S. to use together with an oral antidepressant for both treatment-resistant depression and for people with major depressive disorder who are experiencing thoughts of 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 that [when] left untreated, depression is potentially fatal,” Bill Martin, J&J’s global therapeutic area head of neuroscience, said in an interview.
A Growing Market
Around one-third of the estimated 21 million U.S. adults with major depression battle symptoms — such as persistent feelings of sadness, sleep disturbances, low energy and thoughts of death or suicide — that don’t respond to treatment, according to some estimates.
“For the first time ever, we now have an option that gives patients freedom,” said Dr. Gregory Mattingly, a physician and president of the Midwest Research Group who was involved in Spravato’s original clinical trials.
Spravato’s Approval
The approval is based on a phase four trial, which showed that Spravato alone improved depressive symptoms beginning about 24 hours after treatment and lasting through at least one month. The company has said that the safety profile was consistent with previous clinical data on Spravato’s use in combination with oral antidepressants.
Spravato’s Long Road to Rapid Growth
Spravato blazed a new trail in 2019 as the first new major depression treatment to win 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 get it into the brain quickly.
Conclusion
Spravato’s approval provides a new option for patients with treatment-resistant depression, offering rapid symptom relief and durable symptom relief. The drug’s safety profile is consistent with previous clinical data, and its approval is a significant milestone in the treatment of depression.
FAQs
* What is Spravato?
+ Spravato is a nasal spray used to treat major depressive disorder that is difficult to treat.
* What is treatment-resistant depression?
+ Treatment-resistant depression is when trying at least two standard treatments does little to nothing to improve depression symptoms in a patient.
* How does Spravato work?
+ Spravato 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 get it into the brain quickly.
* What are the potential side effects of Spravato?
+ The warning label cautions about the risk of sedation and dissociation, respiratory depression, suicidal thoughts and abuse or misuse of the drug, among other potential side effects.
* How is Spravato administered?
+ Spravato is only available through a restricted program, meaning it can’t be purchased at a pharmacy and is only administered in certified health-care settings under strict supervision. Users of the medication must also be monitored by a health-care professional for two hours following administration.
