Ketamine Derivative Approved for Treatment of Depression

Esketamine, a drug derived from the anesthetic ketamine, was approved by the FDA in March for use in cases of treatment-resistant depression and cases where a person with depression has failed to respond to more than one anti-depression medication. The drug will be produced by Janssen Pharmaceuticals, the pharmaceutical companies of Johnson and Johnson, and will be available as an intranasal spray under the name Spratavo.

The approval process was not easy for the new medication. Despite being fast-tracked by the FDA as a “breakthrough therapy,” some of the review panel members expressed concerns about potential risks and the mixed outcomes of the drug’s clinical tests.

Some people are wondering why the FDA chose to move forward with esketamine, instead of speeding the approval of ketamine itself as a depression treatment. Currently used off-label for depression and suicidal ideation by clinics around the US and elsewhere in the world, ketamine receives praise from patients, doctors, and researchers for its potential and low cost. Heartfelt testimonials pop up in media outlets as unlikely as Bloomberg News and CBS News.

Ketamine’s chief use is as a veterinary anesthetic, though it is used for human anesthesia as well. One reason the FDA may be shying away from ketamine itself and looking at derivatives is the medication’s longtime illicit use as a recreational drug. The result may mean that ketamine treatment continues to be off-label, unstudied, and available only at high prices, while esketamine is the only game in town for people relying on insurance to pay the bills.