The Food and Drug Administration (FDA) recently approved the nasal spray Spravato for the treatment of major depression in people who have not responded to at least two oral antidepressants.
Johnson & Johnson has announced the FDA’s approval of a first-of-its-kind, esketamine nasal spray called Spravato for the standalone treatment of major depressive disorder (MDD), PTSD, and similar psychiatric conditions.
The announcement was welcome news for those with major depressive disorder, which affects an estimated 8.3% of the adult population.
The NDA is supported by data from a clinical trial that compared the absorption and efficacy of the nasal treatment with oral and IV bumetanide in 68 healthy adults.
The Food and Drug Administration has approved the first-ever stand-alone nasal spray to treat drug-resistant depression. Johnson & Johnson's Spravato was approved to treat a major depressive disorder,
Approval of Spravato, granted following FDA priority review, was based on the results of ... compared with 7.6% of patients taking placebo. Spravato nasal spray is administered by the patient under the supervision of a health care provider in a health ...
The expanded indication allows esketamine nasal spray to be used as a standalone treatment in adults with MDD who have not responded to at least two oral antidepressants.
The U.S. Food and Drug Administration (FDA) approved the antidepressant nasal spray Spravato as a standalone treatment for depression in adults.
A ketamine-based nasal spray is officially the first and only standalone therapy available for treatment-resistant depression in the US. The FDA first approved the Johnson & Johnson drug, called Spravato (esketamine), for some cases of depression in 2019 ...
Share on Pinterest The FDA has approved an esketamine nasal spray for the treatment of depression cases that do not respond to other therapeutic approaches. Image credit: Koldunov/Getty Images.
The U.S. Food and Drug Administration (FDA) has approved the use of a nasal spray as a standalone treatment for major depressive disorder, offering a new option for those struggling with treatment ...
People with treatment-resistant depression can now take Spravato's ketamine-derived nasal spray as a standalone treatment.