The U.S. Food and Drug Administration (FDA) may approve a nasal spray that can help relieve moderate to severe depression within hours instead of weeks. The drug is called esketamine, which is based on the anesthetic ketamine, also called a “mind-altering party drug.”
Esketamine would be a new drug for depression in decades, which works in a different way than standard antidepressants such as Prozac.
Dr. Dennis Charney, dean of the Icahn School of Medicine at Mount Sinai in New York, said, esketamine’s FDA approval would be a great deal. He said, “This is potentially a game-changer for millions of people.”
Charney explained that esketamine works promptly and can help treat a major depressive disorder in patients who fail to notice an improvement with other antidepressants.
He said, “Many of them are suicidal, so it’s essentially a deadly disease when you haven’t responded to available treatments and you’ve been suffering for years, if not decades.”
The dean holds the patents of esketamine and ketamine. He also helped conduct the first clinical trials, which was done a couple of decades ago. The trials showed that the drug could help treat depression.
However, esketamine has a few challenges because of its similarities with ketamine. It has been found that the higher doses of both the drugs can have sedative effects and out-of-body experiences.
Johnson & Johnson, the company that produced esketamine, has promised to ensure that the drug will be used only as intended.
The president of Janssen Neuroscience (a part of Johnson & Johnson), Courtney Billington, said if esketamine is approved, it will be sold under the brand name Spravato.
Billington said esketamine will only be available in a few approved and certified treatment centers. The potency will be very, very low.
The decision of the FDA on approving esketamine comes as many physicians have started prescribing a generic version of ketamine to treat depression. The generic version is approved as an anesthetic, but physicians can prescribe it for other medical purposes.
Dr. Demitri Papolos, director of research for the Juvenile Bipolar Research Foundation, recommends ketamine for depression. He predicts that doctors already are comfortable prescribing ketamine for disorders associated with depression.
Papolos said, “I certainly hope so because it’ll be a lot less expensive and a lot easier for their patients. “The generic form is cheap and can be taken at home in a nasal spray once patients know the right dose.” The drug may not be as effective as its generic version, but any physician or psychiatrist can prescribe esketamine without any restrictions. Generic ketamine costs you only a few dollars. However, it is not clear yet how much esketamine will cost you.
