Advocates for anti-depression therapies are applauding federal regulators for approving the first new treatment for depression in decades — a medication derived from a notorious party drug.
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 is an exciting development and the first novel mechanism that goes beyond the current serotonin treatments,” Dr. Sanjay Mathew of the Anxiety and Depression Association of America said in an interview. “It opens up opportunities for millions.”
The FDA’s approval of Spravato, known generically as esketamine, came less than a month after expert advisers threw their support behind the spray.
The Anxiety and Depression Association of America, based in Silver Spring, Maryland, urged the FDA’s approval to address what has been called one of psychiatry’s most glaring problems.
“The unmet need is really huge,” Dr. Husseini Manji, head of neuroscience therapeutics at Janssen, the subsidiary of Johnson & Johnson that developed Spravato, told the Scientific American magazine.
Spravato is the first new anti-depressant to hit the U.S. market since Prozac in 1988. Prozac, like other anti-depressants, affects the brain chemical serotonin.
Prozac therapy can take weeks or months to become effective, but Spravato has an almost immediate effect as it alters the neurotransmitter glutamate, according to researchers.
Esketamine is derived from the sedative ketamine, which has been used for decades to prepare patients for surgery. Since the 1990s, ketamine has gained notoriety in the underground rave scene as “Special K,” which can produce psychedelic effects.
The FDA’s approval of Spravato is only for patients with depression who have failed to find relief with at least two other drugs.
According to Janssen, treatment costs will depend on dosage and range from $590 to $885 per treatment session. A month of treatments — at two sessions per week — is estimated to cost $4,720 to $6,785, the pharmaceutical company said.
Treatments will be administered at doctor’s offices or clinics, where patients will self medicate with the spray and then be monitored for at least two hours. Doctors said esketamine can cause impair motor functions and cloud judgment.
Some researchers contend that esketamine needs more study and additional clinical trials. In a recent interview with Scientific American, Dr. Erick Turner, a psychiatrist at Oregon Health and Science University, said the drug had undergone only one government-supervised trial and needed a second.
Dr. Mathew, a professor of psychiatry and behavioral sciences at Baylor College of Medicine, pushed back against that. He said that esketamine, as a derivative of ketamine, is not a new drug.
“You could make the argument that it has been studied for years and years and that we certainly have reasonable amounts of data regarding its effects,” he said.
