The U.S. Food and Drug Administration has approved a fast-acting nasal spray that has shown promise in treating depression in patients who have tried other antidepressants without success.
The FDA announced in a press release Tuesday it has approved the drug esketamine for use in adults with treatment-resistant depression.
The spray will be developed by Janssen Pharmaceuticals — a branch of Johnson & Johnson — and will be sold under the brand name Spravato in conjunction with an oral antidepressant.
Esketamine contains the same active ingredients as ketamine, which gained popularity in the ‘80s and ‘90s as a club drug called Special K, according to NBC News.
Because esketamine presents various side effects including sedation and dissociation, Spravato will only be available through a “restricted distribution system.” The drug must be administered in a doctor’s office or clinic, and patients will have to be monitored for at least two hours after receiving the dose.
“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in the release.
Spravato’s effect was seen within two days — a drastic improvement over traditional antidepressants, which typically take weeks to kick in, said the FDA.
Drugmakers believe Spravato will be able to help 30 to 40 percent of patients with treatment-resistant depression, according to NBC, although the relief will not come cheaply. The New York Times reports a one-month course of treatment will be between $4,720 and $6,785 — though it will likely be covered under many insurance plans.
“We’ve had nothing new in 30 years,” Steven Hollon, a professor of psychiatry and behavior sciences at Vanderbilt University, told the outlet. “So 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.”
An estimated 16.2 million American adults, or 6.7 percent of the population, have had at least one major depressive episode, according to the National Institute of Mental Health.
Source: Read Full Article