February 12, 2019
A new depression medication inching toward Food and Drug Administration approval would be the first new treatment option for depression in 35 years.
Inspired by ketamine, a Schedule III dissociative anesthetic, Esketamine is a nasal spray designed to treat severe forms of depression that don't respond to other medications, Business Insider reports.
While Esketamine, which is formulated by Johnson & Johnson, is nearly identical, chemically, to ketamine, it is thought to have slightly fewer side effects than the original compound.
Ketamine appears to engage a different part of the brain from traditional antidepressants, which is part of the reason it's been called "the most important discovery in half a century" for mental illness.
On Tuesday, a panel of outside experts convened by the FDA voted 14-to-2 in favor of the drug's effectiveness and 15-to-2 in favor of its safety. Its recommendation will play a key role in the FDA's approval process for the drug, according to Business Insider.
A decision is expected in March.
According to Med Page Today, unlike other antidepressants, Esketamine’s onset of action can be extremely rapid — hours to days, as opposed to several weeks for standard agents such as selective serotonin reuptake inhibitors, the current gold standard in depression treatments.
Experts are concerned about negative side effects of the drugs. The most troublesome of these, according to analysts and scientists, is the drugs' tendency to produce what are known as dissociative, or "out of body," experiences, Business Insider explains.
Despite that concern, the majority of the FDA’s committee considered the drug to be an effective treatment for severe depression.