The US Food and Drug Administration (FDA) has authorized Johnson & Johnson's nasal spray, Spravato, as the first independent treatment for adults suffering from treatment-resistant depression.
This marks a significant development for patients who have not responded to at least two prior oral antidepressants.
FDA Approves Spravato as Stand-Alone Treatment for Treatment-Resistant Depression
Spravato, initially approved in 2019 for use alongside oral antidepressants, now offers a solo treatment option for individuals with major depressive disorder (MDD) who have struggled to find relief.
Treatment-resistant depression affects about one-third of the 21 million US adults with major depression, who experience persistent symptoms such as sadness, low energy, and thoughts of death or suicide despite various treatments, CNBC said.
The approval follows positive results from a phase four trial, which showed that Spravato alone could rapidly improve symptoms, with improvements beginning within 24 hours and continuing for at least a month.
After four weeks of treatment, 22.5% of patients taking Spravato achieved remission, compared to only 7.6% of those on a placebo.
Johnson & Johnson's Spravato: Rapid Relief for Depression Despite Risks
Bill Martin, Johnson & Johnson's global head of neuroscience, explained that treatment-resistant depression is a complex condition, and for a long time, healthcare providers have had limited options to offer patients the symptom relief they desperately need.
He emphasized that Spravato's approval gives healthcare providers a new tool to personalize treatment and potentially improve outcomes for patients.
While Spravato has shown promise in providing rapid relief, it does come with risks, including sedation, respiratory depression, and the potential for misuse.
As a result, it is only available through a restricted program, where it must be administered in certified healthcare settings under close supervision.
According to CNN, Dr. Gregory Mattingly, who has seen the drug's impact firsthand, believes the approval marks a significant step forward. "For the first time ever, we now have an option that gives patients freedom," he said.
This approval expands the availability of a much-needed treatment option for patients battling depression that is resistant to standard therapies.
