Spravato is now the first-ever standalone therapy for treatment-resistant depression, and is on its way to becoming a blockbuster product.
The Food and Drug Administration approved Johnson & Johnson's nasal spray to be used alone in adults with a major depressive disorder that is difficult to treat, as sales of the drug grow.
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 J&J's Martin said the approval provides"an avenue for caregivers and their patients to really optimize, personalize the treatment paradigm for each individual" and determine the best way for them to manage the disease.
Spravato's 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. Because of that, 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.
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