Many people are impacted by Major depressive disorder (MDD) and Treatment-resistant depression (TRD), yet the conversation around them can often feel distant. TRD and MDD are serious and often invisible struggles, and those who struggle with Treatment- resistant depression can have a complicated mental health journey in seeking alternative treatments. For individuals who are unable to tolerate or do not respond to oral antidepressants, treatment-resistant depression can be extremely complex. Healthcare professionals have had limited alternatives for providing patients with much-needed symptom relief for far too long.
January 21, 2025— Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved SPRAVATO® (esketamine) as the first and only monotherapy for adults with treatment-resistant depression (TRD).
What does this mean?
In short, it no longer requires patients to be on a concurrent traditional oral antidepressant prior to initiating their SPRAVATO® treatment.
The approval of SPRAVATO® as a standalone treatment comes from the results of a study that showed a rapid improvement in Montgomery-Asberg Depression Rating Scale (MADRS) total score vs. placebo. The Phase 4 trial showed that monotherapy SPRAVATO® eased depressive symptoms beginning about 24 hours after treatment and lasting through at least one month. J&J stated that the safety profile was consistent with previous clinical data on Spravato’s use in combination with oral antidepressants.
**MADRS is a tool used to measure the severity of depression based on and is a score that assesses depression symptoms.
What is SPRAVATO® (Esketamine)?
Esketemine is a nasal spray derived from the molecule ketamine, approved by the U.S. Food and Drug Administration (FDA) in 2019 for the treatment of treatment-resistant depression (TRD) and major depressive disorder (MDD) in adults, especially in those who have not responded to conventional antidepressants and other treatments. However, it was used in conjunction with an oral antidepressant.
Eskeatmine is classified as a CIII drug, which speaks to the FDA regulations of its administration to ensure that it is used safely and prevent potential misuse. Esketamine is subject to strict safety guidelines that require patients to be enrolled in the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program to facilitate safe and appropriate use. Patients are to be treated in a medical facility where they can be monitored for any potential side effects: sedation, dissociation, and slight increase in blood pressure. However, not everyone experiences these side effects and effects that do occur often fade naturally out within the hour.
Esketamine works by affecting the brain’s glutamate system, which plays a critical role in regulating mood, cognition, and emotional response. Esketamine, an enantiomer of ketamine, is believed to be more potent and effective than the racemic mixture of ketamine, which is often used in traditional IV ketamine treatments. The nasal spray formulation of esketamine provides a convenient way for patients to administer the drug in a clinical setting, under the supervision of healthcare providers.
Key Features of Esketamine:
- FDA-approved for treatment-resistant depression (TRD)
- Administered as a nasal spray in a supervised medical setting
- Works by blocking the NMDA receptors in the brain to help alleviate depression
- Can provide rapid relief of depressive symptoms, sometimes within 24-48 hours
- Safety regulations made by the FDA to ensure patient safety and effectiveness
Who is SPRAVATO® Monotherapy suitable for?
SPRAVATO® is designed for adults who have not seen positive results from two different antidepressant medications and are considered to be treatment-resistant. These individuals may be ideal candidates for alternative therapies like Spravato®.
You may qualify if you:
Have been diagnosed with MDD and TRD.
Have not had a favorable response to at least two different antidepressants.
Are looking for a rapid-acting treatment option that can be administered in a supervised, controlled setting.
It’s crucial to discuss your treatment history and symptoms with a healthcare provider to determine if SPRAVATO® is appropriate for you. You should avoid using SPRAVATO® if you are under 18, are pregnant or planning to become pregnant, or have a history of substance dependency (including alcoholism), vascular conditions, or prior brain bleeding, uncontrolled hypertension, or any other medical contraindications.
If you’re uncertain whether SPRAVATO® is suitable for you, our knowledgeable team is available to assess your eligibility through a thorough evaluation.
SPRAVATO® as a Monotherapy
The FDA’s approval of Spravato® as a monotherapy changes the treatment standard for TRD using SPRAVATO®. For one, its approval simplifies the treatment and reduces the need for complex medication regimens. Removing the requirement for additional antidepressants, may lower the cognitive and emotional barriers often enhanced by patients navigating treatment-resistant depression.
In addition to broadening its clinical indications, SPRAVATO® as a monotherapy is revolutionizing the way medical professionals treat TRD. This approval provides an alternative to conventional approaches that have failed individuals with TRD and MDD, while also acknowledging the complexity of depression. Fast-acting relief is possible with SPRAVATO® for people who have cycled through year-long medication management treatment. It gives people who have had trouble finding workable answers fresh hope and shows a growing dedication to cutting-edge methods in mental health treatment.
