Suicidal adults can use nasal spray to help ease symptoms within 24 hours, FDA says
Health officials in the U.S. approved a nasal spray designed for adults suffering from suicidal thoughts or behavior — the “first and only” antidepressant medicine shown to help people feel relief with one dose. Some patients improved in as little as four hours.
The U.S. Food and Drug Administration said the spray should be used in conjunction with oral antidepressants and therapy visits with a healthcare professional, according to Janssen Pharmaceutica, the Belgium-based company behind the medication.
Most importantly, its makers say the nasal spray, coined SPRAVATO, provides a new option of “significant symptom relief” for suicidal adults while other longer-term treatments take effect.
“Many people who live with depression know all too well the feeling of desperation. If that major depression progresses to active suicidal thoughts, it’s crushing, and they need options to help change the trajectory of their acute depressive episode,” Theresa Nguyen, chief program officer of Mental Health America, a non-profit organization based in Virginia, said in a news release.
“Traditional oral antidepressants need weeks or more to take effect, so the availability of a medicine that can begin providing relief within a day is potentially life changing,” she added.
The FDA first approved SPRAVATO last year for depressed adults who have had no luck with existing antidepressant medicines, but this time, they added suicidal adults to the mix after conducting additional clinical trials.
It was the first time the FDA approved esketamin — a more potent form of the party drug ketamine that the nasal spray comprises —for any use.
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Patients who were initially hospitalized for suicidal thoughts, took oral antidepressants and attended therapy visits twice a week for four weeks received the medicated nasal spray or a placebo nasal spray during the studies, the company said.
Over 40% of the patients who received SPRAVATO achieved clinical remission of their depression, meaning they showed minimal to no symptoms 24 hours after their first dose; some patients felt relief just four hours into the treatment, according to the company.
Ironically, the drug was not shown to prevent suicide or reduce suicidal thoughts, but it did improve depressive symptoms, which are most frequently associated with suicide, the company said. The most common side effects were feelings of disconnection with oneself, dizziness, sleepiness, high blood pressure and vertigo.
“What we have to be careful of is not to interpret that this is a medication you give once or twice and the person is fine, and you don’t need the follow-up,” Dr. Gerard Sanacora, clinical trial investigator and director of the Yale Depression Research Program, told NPR. “Part of the reason that these studies showed such a big effect was that there was a very comprehensive follow-up plan built into this.”
Suicide is a leading cause of death in the U.S., according to the Centers for Disease Control and Prevention. Nearly 45,000 lives were lost to it in 2016, and suicide rates have increased more than 30% in half of states since 1999.
