The FDA has approved Spravato® (esketamine) nasal spray for use as monotherapy for patients with treatment-resistant depression (TRD), in addition to its use in conjunction with an oral antidepressant. Approval was based on a Phase 4 trial showing monotherapy Spravato eased depressive symptoms beginning about 24 hours after treatment and lasting through at least one month.
Depression that resists treatment can pose significant challenges, particularly for individuals who either do not respond to traditional oral antidepressants or find them intolerable. Spravato® is now accessible as an independent treatment option, allowing patients to potentially see enhancements in their depressive symptoms within just 24 hours and at 28 days – all without the necessity of daily oral antidepressants.
Spravato®
Spravato® was first approved by the FDA in 2019 for alleviating depressive symptoms in adults with major depressive disorder experiencing acute suicidal thoughts or behaviors, used alongside an oral antidepressant.
Spravato® works to treat depression by targeting the NMDA receptor and glutamate system in your brain. Scientific studies have shown the importance of NMDA/glutamate in modulating mood, behavior, memory, and learning. Traditional antidepressants, such as SSRIs and SNRIs, work by altering levels of serotonin and norepinephrine in the brain. While effective for many, they often take several weeks to show benefits and may not work for people with treatment-resistant depression.
Spravato® treatment
Spravato® is self-administered as a nasal spray with direct guidance and clinical supervision of our provider in private treatment rooms. The provider will tell you how to use the device and you will be monitored in the office for about 2 hours after administration. Some patients taking Spravato may experience nausea or vomiting. You should avoid eating two hours before and drinking liquids 30 minutes before taking Spravato. Once the provider decides that it’s safe for you to leave the office, you should have a family member or a friend drive you back home from your appointment.
The most frequently reported adverse effects associated with the treatment included dissociation, nausea, dizziness, headache, anxiety, vomiting, slightly elevated blood pressure, and sedation. However, not everyone experiences these effects. During your treatment session, all effects are monitored closely by our physicians and often last within an hour and fade naturally. No new safety concerns were identified during the trial. Spravato is classified as a class III controlled substance and is exclusively obtainable through a restricted program known as the Spravato REMS. Given the risks of sedation, dissociation, and respiratory depression, administration must occur under the close supervision of a healthcare professional.
Who should consider Spravato treatment?
Spravato® is designed for adults who have not achieved positive outcomes after trying two different antidepressants. Frequently, these individuals are regarded as treatment-resistant and may be optimal candidates for alternative therapies like Spravato®. It is administered under the oversight of a healthcare professional in a medical setting, with each session meticulously monitored to ensure both safety and effectiveness.
You might be eligible if you:
Have been diagnosed with major depressive disorder (MDD) or Treatment-resistant depression.
Have not responded positively to at least two different antidepressant medications.
Are in search of a rapid-acting treatment solution that can be provided in a regulated, supervised setting.
Consulting with a healthcare provider about your treatment history and symptoms is crucial to ascertain if Spravato® is appropriate for you. Use of Spravato® is not recommended for individuals under 18 years of age, those who are pregnant or plan to become pregnant, or individuals with a history of substance abuse, including alcoholism, vascular diseases, a history of cerebral bleeding, uncontrolled high blood pressure, or other medical exclusion criteria.
Spravato® as a Monotherapy
The FDA’s endorsement of Spravato® as a standalone therapy transforms the standard of care for TRD with Spravato®. Firstly, it streamlines the treatment process and diminishes the necessity for intricate medication schedules. Eliminating the requirement for supplementary antidepressants may decrease the cognitive and emotional hurdles that patients often face when dealing with treatment-resistant depression.
Moreover, expanding its clinical applications, Spravato® as a standalone therapy is redefining the approach health care providers take in addressing TRD. This endorsement offers an alternative to traditional methods that have not succeeded for individuals with TRD and MDD, while simultaneously recognizing the intricate nature of depression. Rapid relief is attainable with Spravato® for those who have undergone lengthy medication management cycles. It provides renewed optimism for those struggling to find effective solutions and demonstrates a commitment to innovative strategies in mental health care.
