As part of a key federal advisory panel, Steven Meisel voted in favor of a new nasal drug for treatment-resistant depression — but that doesn’t mean he has no concerns.
A Minneapolis pharmacist and system director for medication safety at Fairview Health, Meisel said there are many valid reasons for concern now that the drug, esketamine, has been approved for the U.S. market, and that he is glad that it is being tightly restricted.
Ultimately, he favored its approval as a member of an advisory panel to the U.S. Food and Drug Administration. Too many people have too few choices when struggling with a form of depression that resists common antidepressant drugs, he said. This form of depression afflicts roughly one third of the 16.2 million Americans who have suffered major depressive episodes.
“These are people who have already failed at least two standard antidepressants,” he said. “If you go to a third one or fourth one or fifth one that acts the same way, you’re basically getting diminishing returns. It’s a very difficult population.”
Fairview Health is preparing to offer esketamine, which will be distributed under the brand name Spravato. Meisel said it shouldn’t be viewed as a “wonder drug,” and that it still only works in a minority of patients with treatment-resistant depression. But, he said, it has almost eliminated depressive symptoms in some patients.
Surveys conducted by the manufacturer, Janssen Pharmaceuticals, suggested that patients were willing to take the risks, considering the potential benefits, although the drug might not be right for patients with heart problems because it elevates blood pressure.
“What sold it for me was the knowledge that there were some people whose lives were changed by it,” Meisel said. “I know full well that if you just keep giving people a different version of the same drug class … their lives will not be improved. And you know, severe depression cannot only affect the patient, it affects their jobs, it affects their families, it affects everything. There is more than one sufferer of depression in that regard.”
Esketamine is chemically similar to ketamine, a sedating anesthetic drug that is sometimes abused recreationally. Abuse of ketamine can cause a “dissociative reaction,” Meisel said. “You feel like you’re out of your body, like you’re not even part of this world.”
Ketamine was controversially used by paramedics at Hennepin County Medical Center in a drug trial to see whether it could safely subdue patients whose agitation posed threats to themselves and others. Critics believe the drug was used excessively and the study wasn’t communicated adequately in advance to the community.
Esketamine’s similarities to ketamine make caution justified, Meisel said. He supported an FDA decision last month that requires patients to receive their nasal dose at a hospital or clinic, then wait for it to take effect and get a ride home. That will present hardships for depression sufferers, he acknowledged, but it will reduce the potential for abuse.
“That’s going to be a major win in terms of making sure the drug doesn’t get out there for party purposes,” he said, “but it is a major inconvenience.”