A medication that’s the chemical cousin of the club drug ketamine has been approved by the US Food and Drug Administration as a fast-acting new treatment for severe depression.
The drug, called esketamine, was green-lit by the agency Tuesday and will be sold as a nasal spray called Spravato, and is made by Janssen Pharmaceuticals, Inc., an affiliate of Johnson & Johnson.
“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research said in a statement Tuesday.
“Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA’s drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment,” Farchione said.
The drug — will cost between $590 and $885 depending on the dosage and before insurance discounts and rebates — is intended for use by adults who have tried other antidepressant medications, but have not benefited from them, the agency noted.
Recently, some doctors have given ketamine to people with depression, without formal FDA approval. But this is the first time the agency has approved esketamine for any use. In the 90s ketamine, known as Special K, was widely abused in clubs and raves.
Spravato’s labeling contains a “boxed warning” that cautions that patients are at risk of “sedation and difficultly with attention, judgment and thinking (dissociation), abuse and misuse, and suicidal thoughts and behaviors after administration of the drug,” the FDA said.
Due to those risks, patients must be monitored by a health care provider for at least two hours after taking the drug.
Due to the risk of serious adverse outcomes resulting from sedation and dissociation caused by Spravato, it will only be available through a restricted distribution system.
“[I]t must be administered in a certified medical office where the health care provider can monitor the patient,” Farchione said.
According to the FDA, “Patients should not drive or operate machinery until the next day after a restful sleep. Spravato may cause fetal harm and women of reproductive potential should consider pregnancy planning and prevention; women should not breastfeed while being treated.”
Up to 7.4 million American adults suffer from treatment-resistant depression, which increases the risk of suicide, hospitalization and other serious harm, the agency said.
There have been no major pharmaceutical advances for depression since Prozac and other antidepressants hit the market in the 1980s.
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