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FDA approves controversial drug for depression

12 March 2019

The decision comes after an FDA advisory panel recommended approval of the drug, Spravato, which is created to treat depression in patients who have not benefited from two or more antidepressants.

The drug is to treat severe symptoms of depression, including adults with treatment-resistant depression (TRD). Ketamine targets a different receptor in the brain and appears to have a more direct effect than those drugs.

One short-term trial that lasted four weeks determined that a combination of Spravato and an oral antidepressant demonstrated a "statistically significant effect" compared to a placebo. Spravato, a mind-altering medication related to the club drug Special K, won US approval Tuesday, March 5, 2019, for patients with hard-to-treat depression, the first in a series of long-overlooked substances being reconsidered for severe forms of mental illness.

The treatment is only available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy (REMS), because of the risk of adverse outcomes resulting from sedation and dissociation.

"There has been a longstanding need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition", said Dr. Tiffany Farchione, acting director of the FDA's Division of Psychiatry Products.

Esketamine is a relative of ketamine, a powerful anesthetic that has been co-opted as a party drug because it can produce euphoric effects and psychedelic experiences.

Treatments will be administered at doctor's offices or clinics, where patients will self medicate with the spray and then be monitored for at least two hours.

The drug comes in the form of esketamine, a mirror image of the ketamine molecule, which is far more potent. More recently, some doctors have given ketamine to people with depression without formal FDA approval. 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. "We have carefully reviewed the drug, and it met our criteria to get approved for depression treatments".

"Spravato will not be dispensed directly to a patient to take at home", he said.

The drug will cost between $590 and $885 depending on the dosage and before various insurance discounts and rebates.

Charney was part of the team that first showed two decades ago that ketamine could treat depression.

In an emailed statement, J&J said Spravato's list price is "generally comparable" with other specialty mental health drugs. During the first month, a patient will have two sessions per week ranging between US$5,000 and US$5,000.

FDA approves controversial drug for depression