Ketamine-based drug approved for treating severe depression in the US

Ketamine-based drug approved for treating severe depression in the US

Ketamine-based drug approved for treating severe depression in the US

Spravato, an esketamine-containing nasal spray developed by Johnson & Johnson, was tested for use with oral antidepressants as a therapy for treatment-resistant depression. Ketamine is a type of anesthesia, and was once a popular party drug known as "Special K".

The agency hopes that the new drug will benefit those who find no relief from antidepressants now available in the market.

Gerard Sanacora, a professor of psychiatry at Yale University School of Medicine, who has led studies sponsored by Janssen and accepted consulting payments from the company, said that he believes the esketamine results have already begun to invigorate the broader field of developing psychiatric drugs. It will be sold under the name Spratavo. More recently, some doctors have given ketamine to people with depression without formal FDA approval.

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

It will be prescribed by doctors for use in conjunction with an oral antidepressant for patients who have tried other forms of antidepressants that have not benefited from them.

Esketamine works on the N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor in the brain. Of that number, a study found that as many as one-quarter are treatment-resistant. Compared to many now available antidepressants that may take weeks or months to produce an effect, esketamine works within hours, according to The Washington Post. Sage Therapeutics (NASDAQ:SAGE), for example, revealed in January that its drug, SAGE-217 met primary and secondary endpoints in a Phase 3 clinical trial to treat postpartum depression. "When I began treatment with esketamine and my symptoms started to lift, I could see very clearly just how depressed I had been", he said.

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

Citing the risk of serious adverse outcomes and the potential for abuse and misuse, the FDA said the drug will be available through a restricted distribution system.

The FDA's approval of Spravato is only for patients with depression who have failed to find relief with at least two other drugs.

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The most common side effects of Spravato include sedation, disassociation, dizziness, nausea, vertigo, lethargy, hypoesthesia or decreased sensitivity, anxiety, increased blood pressure, as well as vomiting.

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