FDA Approves Johnson & Johnson's Nasal Spray Antidepressant | INN

J&J nasal spray gets U.S. approval as first new type of anti-depressant in decades

Esketamine's approval comes as more and more doctors have begun administering a generic version of ketamine for depression.

Lee Hoffer, a medical anthropologist at Case Western Reserve University who studies addiction and the use of illicit drugs, was a member of the FDA advisory committee that recommended last month that the drug be approved.

Data so far indicates that esketamine is safe to use, "but it has to be used in a very well-regulated way to prevent issues related to addiction/substance use", Dr. Hwang says. Spravato is a nasal spray from Johnson & Johnson that's a close cousin of ketamine, an anesthetic that's sometimes used recreationally and often known as "Special K". In comparison, many antidepressants now available can take weeks, or even months, to have an effect. Spravato is meant to treat patients who have major depressive disorder (MDD) and have not responded "adequately" to two at least two different types of antidepressants.

The drug, esketamine, which will be sold by Johnson & Johnson as the nasal spray Spravato, has been highly anticipated by psychiatrists as a powerful new tool to fight intractable depression, according to The Washington Post.

Esketamine is created to be administered intranasally twice a week for an initial 4 weeks, in conjunction with a newly initiated oral antidepressant.

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"Spravato has the potential to change the treatment paradigm and offer new hope to the estimated one-third of people with major depressive disorder who have not responded to existing therapies", said Mathai Mammen, global head of J&J's Janssen Research & Development. He said the approval legitimizes the approach he and other doctors have been taking. The second trial considered in support of the drug was a withdrawal study, and FDA said its division of psychiatry products had not previously considered such a study as one of the primary pieces of evidence for an approval, but added "it is not unreasonable to do so" in its report.

Johnson & Johnson said the wholesale cost of each Esketamine treatment will range from $590 to $885, depending on the dose. In some patients, this improvement was observed within a few days. At least 150 clinics around the USA provide treatment with various forms of the drug, which is available as a low-priced generic.

The Food and Drug Administration approved a controversial drug for depression that could be the first of a long-awaited wave of new treatments, but that has also raised concerns about abuse.

But he hopes that doctors who are now using ketamine continue to do so. The AP is exclusively responsible for all content.

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