The U.S. Food and Drug Administration (FDA) has approved esketamine nasal spray (Spravato) as monotherapy for adults with treatment-resistant depression who have had an inadequate response to at least two oral antidepressants. Johnson & Johnson announced Tuesday.
Use under the supervision of a healthcare provider, Esketamine was approved for the first time In 2019 for use in combination with an oral antidepressant to treat treatment-resistant depression, then received an additional indication in 2020 for adults with major depressive disorder plus severe suicidal ideation or behavior, in combination with an oral antidepressant. The drug acts as a non-selective, non-competitive antagonist of the NMDA receptor and works by targeting glutamate in the brain.
While it is estimated that 21 million American adults live with major depressive disorder, approximately one-third of them will not respond to oral antidepressants alone.
“Patients often take multiple medications orally and wait 4 to 6 weeks for potential relief,” Johnson & Johnson said in a statement. “After trying a third oral antidepressant, approximately 86% of patients do not achieve remission.”
In 379 participants Double-blind trial In support of the new indication, participants who received one of two strengths of esketamine had a significantly greater improvement in mean Montgomery-Asberg Depression Rating Scale (MADRS) total scores compared to placebo at day 28, with lower mean square differences of -5.1 with dose 56. mg and -6.8 at a dose of 84 mg.
In a post hoc analysis, esketamine achieved numerical improvements on all 10 MADRS items by day 28. At week 4, 7.6% of patients taking placebo and 22.5% of patients receiving treatment achieved remission, which was defined as a total score MADRS of 12 or less. .
“For more than 6 years, I have seen first-hand the real-world impact Spravato can have on patients’ lives,” said trial investigator Gregory Mattingly, MD, head of the Midwest Research Group and co-founder of St. Charles Psychiatry USA. Missouri in a statement. “Now that it is also available as monotherapy, healthcare providers are free to further customize treatment plans based on individual needs, so patients can experience the effectiveness of Spravato in as little as 24 hours, through day 28, without the need for daily oral antidepressants.” “
Mattingly previously said MedPage Today This allows patients who have not benefited from standard antidepressants to “liberate themselves from them.” [these treatments] “Which often provided little benefit but were often associated with unwanted side effects.”
Esketamine is labeled with a box warning for risks of sedation, dissociation, respiratory depression, misuse and misuse, and suicidal thoughts and behaviors.
The most common adverse events (occurring in at least 5% of patients) included disorientation, dizziness, nausea, sedation, vertigo, hypoesthesia, anxiety, lethargy, increased blood pressure, vomiting, feelings of intoxication, and headache.
Esketamine should not be used in patients who are breastfeeding; Those with aneurysmal vascular disease, arteriovenous malformation, or a history of cerebral hemorrhage. Those who are allergic to any of its ingredients.
