The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson’s ketamine-derived nasal spray Spravato to treat those with severe depression, the company said on Tuesday.
The drug was first approved in 2019 in combination with antidepressants to treat major depressive disorder.
This new approval allows for Spravato to be a standalone treatment for adults who have had a poor response to antidepressants.
According to J&J, approximately 21 million adults struggle with major depressive disorder , and one-third of these adults don’t have success with antidepressant treatment. As a result, their quality of life has been significantly reduced, an issue that can be attributed partly to treatment-resistant depression, the company says.
“Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them,” said Bill Martin with the company’s innovative medicine department. “For too long, healthcare providers have had few options to offer patients much-needed symptom improvement.”
Spravato has the potential to improve one’s depression within a minimum of 24 hours, according to Martin.
The drug’s approval process underwent a “randomized, double-blind, multicenter, placebo-controlled study” that produced rapid improvement in symptoms, according to the company.
Because there is a risk of abuse, sedation, dissociation, and respiratory depression, Spravato will only be available through a restricted program called the Risk Evaluation and Mitigation Strategy, which means that it can only be administered within a health care setting that has been certified to give the drug to patients who have enrolled in the program.
Ketamine is a Schedule III controlled substance approved for general anesthesia. Because of its psychoactive, psychedelic components, it became a regular party drug in the early 1980s, according to a 2021 study on its illicit use, which is why people aged 16 to 25 are most susceptible to ketamine addiction.
Its Schedule III classification means that it has “less potential for abuse” than heroin, which is a Schedule I drug, or cocaine, which is a Schedule II, according to the U.S. Department of Justice.
In February 2022, the FDA published a compounding risk alert warning of the use of ketamine-based nasal sprays to treat psychiatric disorders because “it may be putting patients at risk.”
Spravato, or esketamine, is a substance derived from ketamine, according to Dr. Adam Kaplin, a psychiatrist with Johns Hopkins Medicine.
“Because it’s more potent, you can use it at a lower dose and theoretically have fewer side effects,” Kaplin, who has studied the drug, said in a statement.
