Mental health professionals should curb their enthusiasm about prescribing a new intranasal spray to treat depression, a onetime federal regulator and current associate professor of psychiatry in the Oregon Health & Science University School of Medicine writes in an analysis published in the journal The Lancet Psychiatry.
Erick Turner, M.D., who serves as a member of the Food and Drug Administration’s Psychopharmacologic Drugs Advisory Committee, writes that esketamine may not be as effective as physicians and patients have been led to believe.
Esketamine, sold under the trade name Spravato, earned FDA approval in March of this year.
The drug is the first prescription for depression derived from ketamine, an anesthetic that has also been used illicitly as a street drug. Esketamine works differently from other antidepressants on the market. It’s intended to treat cases of depression for which other forms of treatment have failed, and it’s the first to be delivered as a nasal spray. However, the FDA also noted cardiovascular side effects, which could be problematic for patients with poorly controlled hypertension, as well as sedation and a type of detachment from reality known as dissociation.
Turner says doctors weighing whether to prescribe esketamine should review the same clinical trial data considered by the Psychopharmacologic Drugs Advisory Committee.
Among the concerns he highlights:
- There was a lax definition of “treatment-resistant” among participants included in clinical trials. “Consequently, clinicians might find that esketamine demonstrates less efficacy among real-world patients with higher levels of treatment resistance,” Turner writes.
- Esketamine was statistically better than placebo in only one of the three short-term trials.
- Its effectiveness appears to be no better than far less-expensive alternatives
“Clinicians and patients might wish to temper their expectations,” Turner writes.
Turner previously served as a medical officer of the FDA, where he reviewed applications by drug companies to determine whether they met FDA criteria for U.S. marketing approval.