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A medication that\u2019s 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.<\/p>\n
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.<\/p>\n
\u201cThere has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,\u201d Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA\u2019s Center for Drug Evaluation and Research said in a statement Tuesday.<\/a><\/p>\n \u201cControlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA\u2019s drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment,\u201d Farchione said.<\/p>\n The drug \u2014 will cost between $590 and $885 depending on the dosage and before insurance discounts and rebates \u2014 is intended for use by adults who have tried other antidepressant medications, but have not benefited from them, the agency noted.<\/p>\n 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.<\/p>\n Spravato\u2019s labeling contains a \u201cboxed warning\u201d that cautions that patients are at risk of \u201csedation and difficultly with attention, judgment and thinking (dissociation), abuse and misuse, and suicidal thoughts and behaviors after administration of the drug,\u201d the FDA said.<\/p>\n Due to those risks, patients must be monitored by a health care provider for at least two hours after taking the drug.<\/p>\n 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.<\/p>\n \u201c[I]t must be administered in a certified medical office where the health care provider can monitor the patient,\u201d Farchione said.<\/p>\n According to the FDA, \u201cPatients 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.\u201d<\/p>\n 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.<\/p>\n There have been no major pharmaceutical advances for depression since Prozac and other antidepressants hit the market in the 1980s.<\/p>\n