Esketamine Approved for Treatment-Resistant Depression

Henrietta Brewer
March 8, 2019

The Food and Drug Administration on Tuesday approved the nasal spray Spravato, which is based on the sedative ketamine, for treating the roughly 4 million American adults who suffer from severe depression but gain little to no benefit from available medicines and therapies.

"This saved my life", Snow said.

"The approval of esketamine is a groundbreaking advance in the treatment of depression, given its novel mechanism of action and time frame at which it produces clinically meaningful improvements", he told MedPage Today.

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

"Substantially different agents are only rarely appearing from pharmaceutical companies or other laboratories", said Dr. Paul Summergrad, a psychiatrist at Tufts University.

Unlike ketamine, psilocybin and MDMA have no legal medical use. But the FDA's approval of esketamine could smooth their path. Depression is the world's largest cause of poor health, anxiety, and disability. In 2017, the USA suicide rate rose to 14 deaths per 100,000 people, the highest rate in at least 50 years, according to federal records.

The FDA approved the drug with restrictions to address those concerns.

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. 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 global head of Janssen Research & Development of J&J, Mathai Mammen, said, "Spravato has the potential to change the treatment paradigm and offer new hope to the estimated one-third of people with major depressive disorder who have not responded to existing therapies".

A decades-old drug, ketamine is already used off-label to treat depression by some doctors.

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. Patients often pay hundreds or thousands of dollars for intravenous infusions of the drug over several weeks or months.

"Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA's drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment", added Farchione.

Although it was approved, the new medication has many risks and is therefore required to be used only under the direct supervision of a physician.

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