A new esketamine nasal spray could provide quick relief from severe depression symptoms. But is it safe to use?
The American Foundation for Suicide Prevention note that suicide is the 10th leading cause of death in the United States, and a disheartening 44,965 people die as a result of suicide every year.
All of this calls for better prevention strategies, as well as more efficient treatments for major depression.
Researchers from Janssen Research & Development and Janssen Scientific Affairs — based in Titusville, NJ, and San Diego, CA — in collaboration with colleagues from the Yale School of Medicine in New Haven, CT, have been looking into a faster-acting drug for people "at imminent risk for suicide."
First author Dr. Carla Canuso and colleagues recently conducted a proof-of-concept, phase II, double-blind study testing the efficacy of an esketamine nasal spray for individuals needing quick relief from symptoms of severe depression and suicidal ideation.
Esketamine is a type of ketamine molecule with anesthetic and antidepressive properties. Unlike ketamine, however, it seems to bring with it fewer side effects — such as hallucinations — making it a potential candidate for the treatment of major depression.
The new study, the results of which have been published in The American Journal of Psychiatry, suggests that this novel nasal spray yields good short-term results for individuals at high risk of suicide.
A quick and effective newcomer?
In their phase II trial, the researchers worked with 68 participants with severe symptoms of major depression, who were split randomly into two groups: one group was assigned treatment with the esketamine spray, and the other was given a placebo.
The volunteers took their assigned treatment twice per week for 4 weeks. All participants continued to follow their regular therapy for depression for the duration of the study.
Dr. Canuso and team monitored the effects of the assigned treatments in three stages: at 4 hours, 24 hours, and 25 days after initial administration.
The individuals who had been assigned the esketamine nasal spray showed a significant improvement in depressive symptoms at 4 and 24 hours after treatment, compared with the participants in the placebo group.
Similarly, a significant improvement in suicidal thoughts was observed in the participants in the esketamine spray group after 4 hours, but not after 24 hours. Also, no benefits were observed at the 25-day mark.
When monitoring potential side effects, Dr. Canuso and colleagues noted that the most common adverse events for the individuals who took esketamine included nausea, dizziness, dissociation, and headaches.
Considering these results, the researchers suggest that intranasal esketamine could be a viable, useful treatment for individuals at high risk of suicide, since traditional antidepressants can take 4–6 weeks to kick in.
Dr. Canuso and team acknowledge the necessity of further research, considering the possible risk that this intranasal spray may lead some individuals to overuse ketamine.
Eventually, the researchers aim to bring this drug to market, but first, the spray must be subjected to a phase III trial before its creators can request its approval by the Food and Drug Administration (FDA).
Additionally, the fact that the study was funded by Janssen Research & Development — a pharmaceutical company under the Johnson & Johnson umbrella — has given rise to some concerns.
One worry is that the drug may be released on the market before all of its potential risks have been appropriately assessed. Another concern is that its financial cost after release might be too high, placing it out of the reach of some patients who need it.