FDA-approved nasal spray for severe depression offers hope for treatment-resistant cases

Major depressive disorder (MDD) remains the most commonly diagnosed mental health condition worldwide, with cases rising each year. Traditional antidepressants often fail to provide relief for many individuals, leading to treatment-resistant depression. Recognizing this growing concern, the Food and Drug Administration (FDA) has recently approved Spravato (esketamine) nasal spray for adults who have not responded to at least two oral antidepressants.

According to previous studies, only about 30% of MDD patients achieve full remission with a single antidepressant, and nearly 50% show no response at all. Dr. Gregory Mattingly, a leading investigator in psychiatric research and a founding partner of St. Charles Psychiatric Associates, highlights the rising prevalence of depression, stating:

“Over the past 20 years, we’ve been losing the battle to depression, with rates nearly doubling in the U.S. Major depression poses one of the greatest health challenges, impacting over 21 million adults, with approximately one-third experiencing treatment-resistant depression. This condition not only affects individuals but also has a profound impact on families and the economy.”

Mattingly has been actively involved in research and clinical trials of Spravato, initially approved by the FDA in 2019. With the new approval, the nasal spray can now be used as a standalone treatment option for MDD patients unresponsive to conventional medications.

What is Spravato?

Spravato, developed by Johnson & Johnson (J&J), is an N-methyl-D-aspartate (NMDA) receptor antagonist that acts on the glutamate neurotransmitter system in the brain. NMDA receptors play a crucial role in mood regulation, cognitive function, and memory formation. By influencing these receptors, Spravato rapidly improves depressive symptoms, offering relief to those with severe, persistent depression.

How Does Spravato Work for Depression?

Spravato’s recent FDA approval is based on a multicenter clinical trial that measured its effectiveness using the Montgomery-Asberg Depression Rating Scale (MADRS). The study found that Spravato provided significant and rapid improvement in depression symptoms compared to a placebo.

Key findings from the trial include:

• By Day 28, Spravato showed marked improvement across all 10 MADRS categories.
• 22.5% of participants taking 84 mg doses achieved full remission (MADRS score ≤12).
• 18.3% of participants on 56 mg doses also achieved remission.
• Only 7.6% of placebo recipients experienced similar remission.

Dr. Mattingly emphasized that before Spravato, no new mechanism of action (MOA) had been introduced in mental health treatments for over 30 years. He believes this approval will allow for more personalized treatment plans, offering hope to patients struggling with treatment-resistant depression.

A Major Step Forward in Depression Treatment

Dr. Eric C. Alcera, Chief Medical Officer at Hackensack Meridian Health, welcomed the FDA’s decision, stating:

“This is a significant advancement for those suffering from MDD. Traditional antidepressants can take weeks to show results, whereas Spravato offers a faster alternative. For individuals who don’t respond to conventional treatments, this could be a game changer, potentially preventing worsening symptoms and even suicide.”

Dr. David Merrill, a board-certified geriatric psychiatrist at Providence Saint John’s Health Center, also endorsed the approval, highlighting the need for more scientifically-backed treatment options:

“Depression treatment must evolve. While traditional antidepressants help some patients, many remain treatment-resistant. FDA approval ensures Spravato’s safe and regulated use, offering quicker relief that can last throughout the treatment period.”

Future Considerations

While Spravato represents a breakthrough in depression management, experts stress the importance of long-term safety studies to assess its effectiveness over time. Dr. Alcera also raised the possibility of alternative delivery methods, such as oral or injectable formulations, for patients who cannot tolerate nasal sprays.

As mental health awareness grows, innovative treatments like Spravato provide renewed hope for patients, families, and healthcare providers battling severe depression.

Disclaimer: This article is for informational purposes only and does not constitute medical advice. Patients should consult their healthcare provider before considering any new treatment.