Anti-depressant nasal spray approved for use

J&J nasal spray gets U.S. approval as first new type of anti-depressant in decades

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. If the drug doesn't work, physicians can quickly switch to other options, he noted.

The U.S. Food and Drug Administration on Tuesday approved Johnson & Johnson's (NYSE:JNJ) nasal spray antidepressant that is chemically similar to often-abused ketamine, marking the first advance in treating depression in more than 30 years.

Some 16 million people in the US have major depression, and one-third of them have not responded well to available treatments and may therefore be considered to have treatment-resistant depression.

The company opted for a nasal spray after concluding that IV administration was impractical and a pill wouldn't get enough of the drug to the brain, according to David Hough, the esketamine team leader at Janssen Research & Development, which is part of Johnson & Johnson.

The FDA's approval of Spravato, known generically as esketamine, came less than a month after expert advisers threw their support behind the spray. He also noted that although ketamine has been available for decades and has been used off-label to treat depression, he hasn't encountered people who now use the drug recreationally in his research and interviews with illicit drug users.

In short, approvals for antidepressants have been few and far between, but with the rising number of people suffering depression, the antidepressant market is undoubtedly poised for growth.

Esketamine is derived from the sedative ketamine, which has been used for decades to prepare patients for surgery.

Robin Prothro, 60, began taking antidepressants more than 20 years ago.

"This saved my life", Snow said. The drug can not be taken home for unsupervised use. "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. After receiving a Spravato dose, a patient must be monitored by a healthcare provider for at least two hours.

The list price of a drug is not necessarily what patients actually pay. "People are saying this is a game changer because it seems like it works well for refractory depression, meaning people who have failed to respond to conventional antidepressant medications and behavioral treatments", Soonjo Hwang, MD, a psychiatrist with the University of Nebraska Medical Center, tells Health. Such therapies are generally not covered by insurance because they haven't been approved as safe and effective by FDA regulators.



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