Ketamine-based drug approved for treating severe depression in the US

Henrietta Brewer
March 12, 2019

Approval of the drug, which will be sold by J&J as Spravato, gives a new treatment option for individuals who have previously failed two or more antidepressants, a population that is estimated to account for roughly a third of the 16 million adults in the us who have had an episode of major depressive disorder.

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. In all three, patients were started on a new oral antidepressant and randomized to receive Spravato or placebo in addition - a design that experts on the advisory committee indicated better reflected how the drug would be used in the real world.

Spravato was evaluated in four clinical studies, during which some users took the nasal spray and an oral antidepressant they hadn't tried before.

The drug will carry a boxed warning that patients taking the drug are at risk for sedation and problems with attention, judgment, thinking, abuse, misuse, and suicidal thoughts and behaviors - the major concerns underlying the REMS.

"There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition", said Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA's Centre for Drug Evaluation and Research. 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. Because ketamine can cause hallucinations and out-of-body experiences, the new drug must be administered in a clinical setting.

According to the FDA, trials of the spray demonstrated a "statistically significant effect compared to placebo on the severity of depression" with some effects noted within two days. 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.

The Food and Drug Administration has recently approved a nasal spray antidepressant based on the widely used anesthetic, ketamine. "It will only be available in approved and certified treatment centers".

Charney was part of the team that first showed two decades ago that ketamine could treat depression.

Johnson & Johnson said the wholesale cost of each treatment with ketamine will range from $590 to $885, depending on the dose.

In an emailed statement, J&J said Spravato's list price is "generally comparable" with other specialty mental health drugs. The health care provider will then observe the patient for treatment-emergent sedation, dissociation and blood pressure changes for at least 2 hours, until the patient is safe to leave.

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