The ongoing debate over the risks and benefits of recently FDA-approved esketamine nasal spray for treatment-resistant depression (TRD) spilled over into a heated toe-to-toe discussion at this week’s American Psychiatric Association (APA) 2019 Annual Meeting in San Francisco.
In March, the US Food and Drug Administration (FDA) approved the drug based, in large part, on a pivotal phase 3 trial. The study findings, which were presented at last year’s APA meeting, were published online this week in the American Journal of Psychiatry (AJP), along with an accompanying editorial. The trial was also the subject of a fully dedicated press briefing at this year’s meeting.
Investigator Michael E. Thase, MD (above), professor of psychiatry at the University of Pennsylvania Perelman School of Medicine, told attendees that the drug was not only effective but also fast-acting, with some improvement evident within the first 24 hours.
Alan F. Schatzberg, MD, Stanford University School of Medicine, California, then made a presentation based on his accompanying editorial, noting that the data are somewhat “worrisome” and that questions remain — particularly with respect to dosing, risk, and the potential for withdrawal symptoms.
Following the two presentations, Medscape Medical News asked whether Thase had any response to Schatzberg’s concerns prompting an extended, sometimes heated, debate between the two physicians.
Thase said he “took issue” with some of the Schatzberg’s criticisms.
“The fact that you can do some good for a large group of people that haven’t been helped by other treatments is the exciting thing,” said Thase, who is also a staff member at the Corporal Michael J. Crescenz VA Medical Center.
“We deal with desperate people every day and any effort to improve their lives should be lauded; but this is coming against a backdrop that will have a significant impact,” Schatzberg responded, noting that desperation is leading to increased use of drugs with abuse potential.
“As a society, we’re going to need to make decisions about what constitutes a reasonable risk-benefit ratio,” he said.
AJP Editor-in-Chief Ned H. Kalin, MD, department of psychiatry, University of Wisconsin School of Medicine and Public Health, Madison, noted that although the trial findings were presented in a poster last year, the journal “isn’t just about new findings” but is also about opening up discussions of current trends in the field of psychiatry.
“We want to be on the forefront of this in relation to the recent FDA approval and wanted to pair it with the commentary. It’s not just the paper but the combination of the two,” Kalin said.
SOURCE: (Full article) https://www.medscape.com/viewarticle/913320
*Also see Med Brief Africa report: Study supports effectiveness of esketamine nasal spray in treatment-resistant depression; https://medbriefafrica.co.za/study-supports-effectiveness-of-esketamine-nasal-spray-in-treatment-resistant-depression/