The United States Food and Drug Administration (FDA) approved an unprecedented nasal spray medication for treatment-resistant depression on March 5, 2019. The new medication is indicated for patients who have cycled through multiple treatments without relief.
The Spravato nasal spray is produced by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. It will be available in the United States, only for the treatment of depression in adults, at a certified doctor’s office or clinic. The FDA points out the risk of serious side effects and the potential for abuse and misuse of the new drug.
The clinical studies for Spravato included three short-term clinical trials and one longer-term trial with more than 1,700 patients suffering from treatment-resistant depression (TRD). In the long-term study, patients “who continued treatment with the medicine were 51 percent less likely to relapse versus those who maintained a regimen of a placebo and an oral antidepressant”, according to the company’s press release.
This is the first FDA approval of esketamine for any use, a chemical substance related to ketamine, which was approved for anesthetic use back in 1970.
According to a 2017 study published in the Journal of the American Medical Association, 16,7% of adults in the United States take some sort of psychiatric medication. By 2011 the most popular antidepressant in the country (and correction) was Celexa, which the FDA approved in 1998. The approval of the esketamine treatment is the biggest pharmaceutical advance in the fight against depression in the past 21 years.