The FDA’s new approval offers hope for those enduring the challenges of treatment-resistant depression.
Key Takeaways
- Spravato, a nasal spray, has been approved by the FDA for treatment-resistant depression.
- Derived from ketamine, it is said to be offering rapid relief, often within 24 hours.
- Patients must use it with a conventional antidepressant.
- The treatment is observed in clinical settings due to perception-altering effects.
- Side effects are typically temporary, subsiding within two hours.
A Revolutionary Approach to a Long-Standing Problem
Spravato, a nasal spray developed by Johnson & Johnson, represents a notable breakthrough for adults with treatment-resistant depression. The U.S. Food and Drug Administration’s approval introduces hope for patients for whom at least two oral antidepressants have failed. Affecting about 21 million adults in the U.S., major depressive disorder poses a considerable challenge, especially for the one-third who do not respond to standard treatments.
Spravato is derived from esketamine, a more potent compound of ketamine, allowing the use of lower doses. This ketamine-derived therapy offers rapid symptom relief, often noticeable within hours, and has undergone extensive scientific validation for its effectiveness.
The Practical Application and Its Implications
Esketamine, the active ingredient in Spravato, is administered as a nasal spray in a clinical setting. This process helps monitor patients due to its potential to distort perception. Patients self-administer three doses under medical supervision. The administration is critical because side effects such as hallucinations, nausea, and increased blood pressure—although temporary—require observation until they subside.
“For people who haven’t had success with other antidepressants, esketamine gives them the chance to see what it’s like to not have depression,” says Adam Kaplin, M.D., Ph.D.
In addition to using Spravato, patients continue taking their regular antidepressants to maintain the rapid relief after the spray’s effects diminish. This groundbreaking approval follows FDA priority review, substantiated by over a decade of research and six years of real-world evidence, and positions Spravato as the first monotherapy for severe depression when other treatments are ineffective.
A New Frontier in Depression Treatment
Spravato works distinctively by increasing levels of glutamate, rather than targeting serotonin, norepinephrine, and dopamine like conventional antidepressants. This mechanism allows it to influence more brain cells, providing quicker relief and reducing suicidal thoughts. The drug’s capacity to possibly help the brain form new connections offers promising solutions against the detrimental effects of untreated depression.
“For the first time in 60 years, we have a new antidepressant therapy that isn’t just a spinoff of existing drugs,” says Kaplin.
With over 140,000 patients globally receiving Spravato, its crucial role in reducing depression symptoms quickly and decreasing relapse time is clear. Despite its groundbreaking attributes, the therapy is accompanied by potential side effects which must be carefully managed, underlining its need for a clinical setting.
