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Saturday, 8 February, 2025
HomeHarm ReductionJ&J’s ketamine nasal spray approved by FDA

J&J’s ketamine nasal spray approved by FDA

The US Food and Drug Administration has expanded approval for Johnson & Johnson’s ketamine-derived nasal spray, Spravato, to allow it to be used as a standalone treatment for patients with severe depression.

The drug was first approved in 2019 to be used in combination with antidepressants, and later, for patients experiencing suicidal thoughts or actions, Reuters reports.

“Now that it is also available as a monotherapy, healthcare providers have the freedom to further personalise treatment plans based on individual needs,” said Gregory Mattingly, founding partner of St Charles Psychiatric Associates.

Spravato bought in sales of $780m for the first nine months of 2024.

MDD (major depressive disorder) is one of the most common mental health disorders in America, according to the National Institutes of Health. About 21m adults experienced at least one depressive episode in 2021, latest government data show.

J&J said about a third of adults will not respond to oral antidepressants alone. 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 with 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 anaesthetic 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 programme.

 

Reuters article – FDA approves standalone use of J&J's ketamine-derived depression treatment (Open access)

 

See more from MedicalBrief archives:

 

Enthusiasm but also caution over new depression drug

 

Ketamine better than ECT for depression – Harvard study

 

Ketamine promising in treating major depression and suicidal thoughts

 

UK licences radical ketamine-like drug to treat depression

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