Morning Briefing
Summaries of health policy coverage from major news organizations
FDA Approves Medication Related To Party-Drug 'Special K' In First Major Depression Treatment To Hit Market In Decades
The Associated Press: FDA Allows Treatment Of Depression With Club Drug's Cousin
A mind-altering medication related to the club drug Special K won U.S. approval Tuesday for patients with hard-to-treat depression, the first in a series of long-overlooked substances being reconsidered for severe forms of mental illness. The nasal spray from Johnson & Johnson is a chemical cousin of ketamine, which has been used for decades as a powerful anesthetic to prepare patients for surgery. (3/5)
The New York Times: Fast-Acting Depression Drug, Newly Approved, Could Help Millions
The move heralds a shift from the Prozac era of antidepressant drugs. The newly approved treatment, called esketamine, is a nasal spray developed by Janssen Pharmaceuticals Inc., a branch of Johnson & Johnson, that will be marketed under the name Spravato. It contains an active portion of the ketamine molecule, whose antidepressant properties are not well understood yet. “Thank goodness we now have something with a different mechanism of action than previous antidepressants,” said Dr. Erick Turner, a former F.D.A. reviewer and an associate professor of psychiatry at Oregon Health & Science University. “But I’m skeptical of the hype, because in this world it’s like Lucy holding the football for Charlie Brown: Each time we get our hopes up, the football gets pulled away.” (Carey, 3/5)
The Washington Post: Esketamine: FDA Approves New Antidepressant To Treat Most Debilitating Cases
The label for the drug will carry a black box warning – the most serious safety warning issued by the FDA. It will caution users they could experience sedation and problems with attention, judgment and thinking, and that there’s potential for abuse and suicidal thoughts. People who take esketamine will have to be monitored for at least two hours after receiving a dose to guard against some of these side effects. (Johnson and McGinley, 3/5)
NPR: Ketamine-Derived Drug Spravato For Major Depression Gets FDA Approval
But esketamine presents some challenges because of its similarities to ketamine. In high doses, both drugs can cause sedation and out-of-body experiences. And ketamine, often called Special K in its illicit form, has become a popular party drug. So Johnson & Johnson is taking steps to make sure esketamine will be used only as intended, Billington said. "Spravato will not be dispensed directly to a patient to take at home," he said. "It will only be available in approved and certified treatment centers." (Hamilton, 3/5)
The Wall Street Journal: FDA Approves Controversial Drug For Depression
The discovery that ketamine can help ease symptoms of depression—and within hours, rather than the weeks required for antidepressants such as Prozac or Zoloft—has shaken up the field of psychiatry. Ketamine targets a different receptor in the brain and appears to have a more direct effect than those drugs. “It really has opened up a whole new way of thinking about depression,” Gerard Sanacora, professor of psychiatry at Yale University School of Medicine and director of the Yale Depression Research Program, said of ketamine. Dr. Sanacora was an investigator on some of J&J’s clinical trials of Spravato. (McKay and Loftus, 3/5)
The New York Times: How To Quit Antidepressants: Very Slowly, Doctors Say
Thousands, perhaps millions, of people who try to quit antidepressant drugs experience stinging withdrawal symptoms that last for months to years: insomnia, surges of anxiety, even so-called brain zaps, sensations of electric shock in the brain. But doctors have dismissed or downplayed such symptoms, often attributing them to the recurrence of underlying mood problems. The striking contrast between the patients’ experience and their doctors’ judgment has stirred heated debate in Britain, where last year the president of the Royal College of Psychiatrists publicly denied claims of lasting withdrawal in “the vast majority of patients.” (Carey, 3/5)
Stat: FDA Approves Esketamine, First Major Depression Drug In Decades
Not all experts are convinced there was enough data to approve esketamine yet. “The threshold has been two adequate and well-controlled trials. In this case, they only got one,” Dr. Erick Turner, a psychiatrist at Oregon Health and Science University, told STAT in an interview last month. Turner serves on the FDA advisory committee that recommended last month that the FDA approve esketamine, but didn’t take part in that meeting. (Thielking, 3/5)
