Depression impacts 300 million people worldwide, yet we haven’t seen a truly new depression drug since Prozac, which came out in 1988. And that’s not because Prozac was the pinnacle of depression treatments. In fact, it doesn’t work for an estimated 1 in 4 patients. But this week the Food and Drug Administration approved Esketamine, a chemical cousin of the party drug Special K, to treat depression. Beyond helping those impervious to Prozac’s charms, Esketamine may treat depression in just hours, and do so less invasively than other ketamine treatments.
“This is potentially a game changer for millions of people,” Dr. Dennis Charney, dean of the Icahn School of Medicine at Mount Sinai in New York, told NPR. “It offers a lot of hope.”
Esketamine’s approval is likely cathartic for Charney, who spearheaded the effort two decades ago to demonstrate that ketamine could help treat depression in patients who do not respond to Prozac. “Many of them are suicidal,” Charney said. “It’s essentially a deadly disease when you haven’t responded to available treatments and you’ve been suffering for years if not decades.”
In recent years Ketamine clinics have popped up across the country, offering the generic anesthetic intravenously. But these treatments usually must be paid for out of pocket, and have many of the same side effects as the hallucinogenic party drug. Esketamine, on the other hand, promises fewer out-of-body experiences and is administered by nasal spray rather than invasive IV-based treatment. Also, since it is FDA approved, it will likely be covered by major insurers.
Still, some experts are concerned. Early Esketamine trials had mixed results, with some trials showing that the treatment was no better at treating depression than a placebo. Although Esketamine did not meet the FDA’s usual efficacy standards, the agency moved the drug along. “Historically, the F.D.A. has required that a drug succeeds in two short-term trials before it is approved,” according to The New York Times. “The agency loosened its criteria for esketamine.” It also remains unclear how well Esketamine works in older patients, and whether administering it nasally might make it less effective than ketamine treatments available in clinics.
Concerns aside, however, Esketamine is the first concrete step that we have seen in decades to solve a mental health crisis that kills. And that has researchers and mental health professionals alike excited. “We’ve had nothing new in 30 years,” Steven Hollon of Vanderbilt University told The New York Times. “If this drug is an effective way to get a more rapid response in people who are treatment resistant, and we can use it safely, then it could be a godsend.”