Published: Tue, March 12, 2019
Medical | By Vicki Mclaughlin

J&J prices ketamine-like depression treatment at $590-$885 for two doses

J&J prices ketamine-like depression treatment at $590-$885 for two doses

There's a new ally in the ongoing battle against depression that doctors say works faster and more efficiently than previous drugs.

That means about 5 million of the 16 million people in the US with major depression might benefit from esketamine, said Courtney Billington, president of Janssen Neuroscience, a unit of Johnson & Johnson. Johnson & Johnson's new nasal spray contains the chemical mirror image of ketamine, which has previously been called a "party drug" because of its quasi-psychedelic effects. But the FDA's approval of esketamine could smooth their path.

Spravato is the first new anti-depressant to hit the USA market since Prozac in 1988.

Citing the risk of serious adverse outcomes and the potential for abuse and misuse, the FDA said the drug will be available through a restricted distribution system.

Only one other drug, a combination of olanzapine and fluoxetine, is approved for treatment-resistant depression, although there are several drugs used off-label.

The FDA's approval of Spravato, known generically as esketamine, came less than a month after expert advisers threw their support behind the spray.

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The US Food and Drug Administration has approved esketamine to treat adults whose depression hasn't responded to other antidepressants, the agency announced in a statement yesterday (March 5). They pointed to reported trial protocol violations, discrepancies between locked data sets and an unusual response curve shift, whereby a almost significant treatment effect emerged 28 days following initiation of treatment, when for three weeks there was no difference, and the other studies showed an effect after only two days.

In that trial, patients in stable remission on Spravato were 51% less likely to relapse compared to those who continued on a regimen of placebo plus oral antidepressant.

"My concern is that we don't really how it gets people un-depressed", Mark George, MD, a psychiatrist and neurologist at the Medical University of SC in Charleston, tells Health. The drug can not be taken home for unsupervised use. Spravato could be available within days at centers to complete the REMS certification. He has researched ketamine and used it to treat depression. Thus each time the patient takes Spravato, they need to be monitored for at least two hours, the manufacturers warn. During the first month, patients will be treated twice a week.

The list price of a drug is not necessarily what patients actually pay.

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

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