The U.S. Food and Drug Administration (FDA) this week approved Johnson & Johnson’s Spravato (a ketamine-derived) nasal spray to treat major depressive disorder (MDD). It marks the first standalone MDD treatment for adults who haven’t responded to at least two oral antidepressants.
This follows a priority review and highlights the drug’s potential to quickly ease depressive symptoms in patients otherwise resistant to treatment.
Treatment-Resistant Depression
Roughly 21 million U.S. adults live with MDD. And about a third of those patients can’t get relief from traditional oral antidepressants. These patients, classified as having treatment-resistant depression (TRD), incur significant societal and economic burdens. They’re responsible for nearly half of the healthcare costs related to MDD.
“Treatment-resistant depression is an incredibly challenging condition to address,” Bill Martin, MD, Global Therapeutic Area Head for Neuroscience at Johnson & Johnson. “With Spravato now approved as a monotherapy, patients have access to a treatment that offers meaningful symptom improvement as early as 24 hours, continuing through 28 days, without the need for daily oral antidepressants.”
Background
Regulators based their approval on the data culled from a randomized, double-blind, placebo-controlled study. Results showed the drug offered quick relief and much better efficacy than the placebo, according to the Montgomery-Asberg Depression Rating Scale (MADRS).
By the fourth week of the trial, more than 22 percent of patients on SPRAVATO® achieved remission – scoring below 12 on MADRS – versus 7.6 percent taking the placebo.
“Having prescribed Spravato for over six years, I’ve seen its profound impact on patients,” Midwest Research Group President Gregory Mattingly, MD, explained. “This new monotherapy approval allows us to tailor treatments further, enabling patients to experience relief within just 24 hours.”
Spravato works by targeting glutamate, the brain’s widespread excitatory neurotransmitter. While the mechanics remain murky, this novel treatment sets it apart from oral antidepressants.
Hope Moving Forward
Caregivers have administered the drug to more than 140,000 patients across 77 countries.
“The approval of intranasal esketamine as a monotherapy for TRD is a significant step forward, in that it will make this treatment a more appealing option for a subset of patients who’d prefer not to take a traditional oral antidepressant alongside intranasal esketamine,” Stella Mental Health Chief Psychiatrist Brian Boyle, MD, said. “Patients seek esketamine precisely because oral antidepressant medications haven’t helped enough or have caused intolerable side effects.
“Indeed, there are patients who may have benefited greatly from esketamine, who in the past have declined to pursue esketamine because of the requirement that they continue to take an oral antidepressant,” Boyle added. “Now, these patients will have access to what they need, an antidepressant treatment that gets them better, faster, without the side effects that often come with a medication that must be taken every day.”
Further Reading
Study Highlights Increased Mortality Risks in Difficult-to-Treat Depression
Barriers to Esketamine Nasal Spray Treatment Among Adults With Treatment-Resistant Depression
