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For people who have cycled through multiple antidepressants without meaningful relief, the FDA-approval of SPRAVATO® marked a significant turning point in how treatment-resistant depression (TRD) is approached. SPRAVATO® (esketamine) became the first nasal spray cleared by the FDA specifically for adults whose depression had not responded to other medications.
At Shore Clinical TMS & Wellness Center, Dr. Srisai Gowda offers SPRAVATO® as part of a fully integrated psychiatric care model that brings together the most advanced interventional psychiatry options available.
The FDA granted clearance to SPRAVATO® treatment after several clinical trials demonstrated meaningful symptom improvement in patients who had tried two or more antidepressants without adequate results.
Unlike traditional antidepressants that target serotonin or norepinephrine systems and can take weeks to act, esketamine works through NMDA receptor modulation, a distinct mechanism that can produce results within hours of the first session. That speed of action is clinically meaningful for patients in acute need.
Before granting clearance, the FDA reviewed data from multiple Phase III clinical trials examining SPRAVATO® esketamine in patients with treatment-resistant depression (TRD) as well as those with major depressive disorder (MDD) and active suicidal ideation with intent. The trials evaluated both symptom reduction and durability of response over time. Importantly, SPRAVATO® was studied as an adjunct to an oral antidepressant, which is how it is used in clinical practice today.
The FDA also established a Risk Evaluation and Mitigation Strategy (REMS) program for SPRAVATO®, which requires that the medication be administered only in a certified healthcare setting with a mandatory two-hour observation period following each session. This protocol exists because of the potential for sedation and dissociative effects during and after administration.
Shore Clinical TMS & Wellness Center is a certified SPRAVATO® treatment center, so every session takes place under close clinical supervision with Dr. Gowda’s team on hand throughout.
In practice, the FDA-approved protocol for esketamine treatment involves an induction phase during the first four weeks, with sessions twice per week, followed by a maintenance phase where sessions gradually taper to once weekly and then once every two weeks. Patients self-administer the nasal spray under observation, and the dose is calibrated to 56 mg or 84 mg based on tolerability and clinical response. The treatment is always combined with a concurrent oral antidepressant.
It is worth noting that the FDA-approved indication covers TRD and, separately, MDD with acute suicidal ideation or behavior. The distinction matters clinically, as the latter indication is intended for use in settings equipped to manage psychiatric emergencies.
At Shore Clinical TMS & Wellness Center, Dr. Gowda evaluates each patient carefully to determine which indication applies and how SPRAVATO® fits within a broader care plan that may include TMS, IV ketamine, or medication management.
Understanding the FDA-approval of SPRAVATO® is a meaningful first step, but the next one is speaking with a clinician who can assess whether it is right for you.
Shore Clinical TMS & Wellness Center is the only psychiatric practice in New Jersey offering medication management, TMS, SPRAVATO®, and IV ketamine under one roof, all guided by Dr. Srisai Gowda’s expertise in interventional psychiatry.
Contact us today to schedule your appointment and take a concrete step toward achieving remission.