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Depression Drug Related to Ketamine Wins FDA Approval

 

By Jonathan Block

March 6, 2019

Depression Drug Related to Ketamine Wins FDA Approval

The FDA has approved Spravato (esketamine), the first new kind of antidepressant in decades, for treatment-resistant depression. The approval follows an FDA advisory committee meeting last month in which members overwhelmingly recommended Spravato’s approval.

The approval of Spravato, which is administered as a nasal spray, is somewhat controversial as the drug is considered a chemical cousin of ketamine, an anesthetic that some abuse as a party drug due to its hallucinogenic effects. The prescribing label for Spravato contains a “black box warning” about the possibility of abuse and misuse while taking the drug.

There is also a question of how effective the drug is considering that in some late-stage trials, the drug was not better than a placebo in reducing depressive symptoms. However, ketamine has been used off-label for years to treat depression and anxiety in infusion centers. Many who have used ketamine in this setting say the antidepressant effects appear within hours, as opposed to weeks with conventional antidepressants.

Spravato may find a large market considering that about one-third of people in the US with major depressive disorder have a treatment-resistant depression, a kind of depression in which an individual’s symptoms are not alleviate despite trying several antidepressants. Most of the antidepressants available now are selective serotonin reuptake inhibitors (SSRIs), the first of which, Prozac (fluoxetine), was approved in 1987.

Spravato is indicated for patients who have tried and failed on at least two prior antidepressants. While taking the drug, patients will also need to take an oral antidepressant. Because of the risk of dissociation (hallucinations) and sedation, Spravato will not be available to patients at pharmacies to use at home. Instead, they will have to go to certified treatment centers where a health care professional will observe them for at least two hours after administration.

Each treatment session doesn’t come cheap – it will cost between $590 and $885, based on dose. The cost for the first month of treatment can range from $4,720 to $6,785. Because the number of treatments needed declines after the first month, subsequent months will cost between $2,360 and $3,540 a month. These are the retail costs and insurers will have to decide whether to cover Spravato.

 

Last updated: March 6, 2019