FDA Approves Ketamine-Derived Nasal Spray Treatment for Depression

The Food and Drug Administration (FDA) recently announced their approval of a ketamine-derived nasal spray drug in treating depression. The drug, Spravato (esketamine), is a chemical relative to the anesthetic and party drug and represents the first new class of depression drug treatments since the introduction of Prozac in 1988.

This nasal spray was approved for use in concert with an oral antidepressant in treating depressed adults who have shown resistance to other depression treatments available. Being that Spravato presents potential adverse outcomes relating to sedation, dissociation, and abuse, it is currently only available through a restricted distribution system under a Risk Evaluation and Mitigation Strategy (REMS). Specifically, eligible patients are those with major depressive disorder who have not responded to at least two antidepressant treatments with adequate dosages during the current episode.

“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” said Tiffany Farchione, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “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. Because of safey concerns, the drug will only be available through a restricted distribution system and it must be administered in a certified medical office where the health care provider can monitor the patient.”

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Esketamine utilizes a mechanism similar to drugs like Prozac, explained Dr. Dennis Charney, dean of the Icahn School of Medicine at Mount Sinai in New York. Charney was a member of the team that first showed ketamine’s efficacy in treating depression two decades ago. He is also co-inventor on the patents filed by the Icahn School of Medicine regarding treating patients with resistance to antidepressants.

The spray is self-administered by the patient in the doctor’s office or clinic and cannot be taken home. The physician will provide detailed instruction as to how to operate the nasal spray device and will check the patient during and after administration to deem if they are ready to leave.

The drug’s efficacy was tested in three short term clinical trials and one long-term maintenance-of-effect trial. The short studies randomized patients to receive either Spravato spray or placebo. Due to the serious nature of treatment-resistant depression and need for patients to receive treatment, all patients in the studies were started a new oral antidepressant treatment at the commencement of randomization and the new drug treatment was continued during the trials.

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The observed outcome was the change from a baseline score on a scale used to assess severity of depressive symptoms. In these studies, Spravato displayed statistically significant effects compared to placebo in alleviating depression, with effects occurring in as rapidly as two days.

J&J noted that the drug’s wholesale cost for each treatment will range from $590 to $885, depending on the dose. This cost of twice-weekly treatments during the first month will cost centers offering the drug at least $4,720 to $6,785. Subsequent treatments will cost these centers roughly half as much.

Source: FDANPR