Reuters
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The U.S. Food and Drug Administration expanded approval for Johnson & Johnson’s nasal spray, Spravato, to allow it to be used as a standalone treatment for patients with severe depression, the company said on Tuesday.
The ketamine-derived drug was first approved in 2019 to be used in combination with antidepressants, and later for patients experiencing suicidal thoughts or actions.
“Now that it is also available as a monotherapy, healthcare providers have the freedom to further personalize treatment plans based on individual needs,” Gregory Mattingly, founding partner of St. Charles Psychiatric Associates, said in a statement.
Spravato bought in sales of $780 million for the first nine months of 2024.
MDD is one of the most common mental health disorders in the U.S., according to the National Institutes of Health. About 21 million U.S. adults in 2021 experienced at least one depressive episodes, latest government data shows.
J&J said that about a third of adults will not respond to oral antidepressants alone.
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Spravato’s approval for standalone use is based on a study in which patients treated with the therapy showed a rapid and superior improvement in severity of depressive episodes, compared to placebo.
More than a fifth of patients taking Spravato went into remission, the company said.
The drug works by targeting a neurotransmitter glutamate, which plays a key role in functions. Esketamine, the chemical name for Spravato, is a chemical mirror image of anesthetic ketamine, which is also abused as a recreational party drug and goes by the street nickname “Special K”.
J&J said that the mechanism by which esketamine exerts its antidepressant effect is unknown. Due to the potential risk of misuse, Spravato is only available through a restricted program.
The Food and Drug Administration (FDA) has recently approved the standalone use of Johnson & Johnson’s ketamine-derived depression treatment, marking a significant milestone in the field of mental health treatment.
This groundbreaking decision allows for the use of esketamine nasal spray without the requirement of also taking an oral antidepressant. Esketamine, a variation of the anesthetic ketamine, has shown promising results in treating patients with treatment-resistant depression.
The approval of esketamine for standalone use provides a new option for individuals who have not responded to traditional antidepressant medications. This decision paves the way for a more personalized approach to treating depression, offering hope for those who have struggled to find relief from their symptoms.
As mental health issues continue to rise, this approval represents a significant step forward in expanding treatment options for individuals suffering from depression. It is a testament to the ongoing research and innovation in the field of mental health, and provides new hope for those in need of effective treatment.
Overall, the FDA’s approval of J&J’s esketamine nasal spray for standalone use is a welcome development that has the potential to positively impact the lives of many individuals struggling with depression.
Tags:
- FDA approval
- J&J
- Ketamine-derived
- Depression treatment
- Standalone use
- Mental health
- Pharmaceutical industry
- FDA regulations
- Innovation in healthcare
- Treatment options
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