FDA Shows Green Signal for Johnson & Johnson's Fast-Acting Depression Drug

Alicia Farmer
March 8, 2019

The nasal spray, from Johnson & Johnson, has been approved for use by the US Food and Drug Administration (FDA) and is the first treatment to tackle depression in a new way for decades. Esketamine contains a component of ketamine, which is used to treat pain, and has also been used as a party drug. The company announced that it was going to close down its 87 U.S. pop-up stores which showcased devices like its Echo, Kindles and other new products. It's meant to treat people who have not found relief through other antidepressants.

In the United States, an estimated 16 million adults live with depression.

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The approval of Spravato could potentially open the door for other types of antidepressant approvals in 2019, particularly in postpartum depression.

The drug's approval came after only one positive short-term phase III trial.

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Esketamine has been advised to be used as a adjuvant along with other conventional antidepressants. Additionally, the prescription is only suggested for those with treatment-resistant depression, meaning that their depressive symptoms have not responded to at least two forms of more conventional anti-depressant drugs. A decade ago, he noted, companies began to abandon the effort. "The threshold has been two adequate and well-controlled trials". Whether a patient stays on the drug for more than six months or a year will be up to the patient and his or her doctor, he said. "Because of safety concerns, the drug will only be available through a restricted distribution system, and it must be administered in a certified medical office where the health care provider can monitor the patient". Patients are required to sign a form attesting that they understand they need to make arrangements to safely get home and that they can not drive or use heavy machinery on the day they receive the drug.

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.

A long term study of the drug showed that patients in stable remission taking the drug that continued the treatment were 51 percent less likely to relapse as compared to those who continuously took a placebo with an oral antidepressant.

"This is going to bring in some standards, regulation and it's going to make it safer and more accessible to patients", said Levine, who serves as vice president of the American Society of Ketamine Physicians, a group representing doctors, nurses and others using ketamine for treating depression or other nonapproved uses.

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