SPRAVATO® (esketamine) CIII nasal spray is a nonselective, noncompetitive antagonist of the N-methyl-D-aspartate (NMDA) receptor – an ionotropic glutamate receptor. It is a first-of-its kind medicine approved by the FDA in two major depressive disorder (MDD) subpopulations with high unmet need.

SPRAVATO® is approved in the United States, in conjunction with an oral antidepressant, to treat adults with treatment-resistant depression (TRD) and to treat depressive symptoms in adults with MDD with acute suicidal ideation or behavior.

Limitations of Use

The effectiveness of SPRAVATO® in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated. Use of SPRAVATO® does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of SPRAVATO®. SPRAVATO® is not approved as an anesthetic agent. The safety and effectiveness of SPRAVATO® as an anesthetic agent have not been established.

SPRAVATO® is available only through a restricted distribution program called the SPRAVATO® REMS. A REMS program is in place to ensure the safety of all patients who are treated with SPRAVATO®. The goals of the REMS are to mitigate the risks of serious adverse outcomes resulting from sedation and dissociation caused by SPRAVATO® administration, and abuse and misuse of SPRAVATO®, by:

• Ensuring SPRAVATO® is only dispensed and administered to patients in medically supervised healthcare settings that monitor these patients

• Ensuring pharmacies and healthcare settings that dispense SPRAVATO® are REMS certified

• Ensuring patients are informed about serious adverse outcomes from dissociation and sedation and the need for monitoring

• Enrolling all patients who receive treatment in an outpatient healthcare setting in a REMS registry to further characterize the risks and support safe use

Patients’ first visit may be a consultation to discuss the details with a healthcare provider at the certified SPRAVATO® treatment center to determine if SPRAVATO® is considered an appropriate treatment option. If SPRAVATO® is recommended, the healthcare provider will discuss important safety risks and enroll patients in the SPRAVATO® REMS Program prior to treatment initiation.

Although related to ketamine, SPRAVATO® is unique because it has been specifically tested in controlled clinical trials for depression and received FDA approval for treating TRD and MDD with acute suicidal ideation or behavior.

SPRAVATO® offers several key benefits for those with treatment-resistant depression. Many patients experience rapid symptom relief. Its convenient nasal spray form makes it an accessible, non-invasive treatment, and it works by targeting specific brain receptors associated with mood regulation, providing an alternative approach to traditional antidepressants.

SPRAVATO® therapy is specifically approved for adults who have treatment-resistant depression, meaning those who have not found sufficient relief from at least two different antidepressant treatments during the current depressive episode. Eligibility is determined after a thorough evaluation by a healthcare provider at our clinic.

During a SPRAVATO® treatment session, you will be seated comfortably in a quiet, supportive environment at our facility. After administering the nasal spray under the supervision of our trained healthcare professionals, you will be monitored for at least two hours for any side effects and to ensure your safety. The entire session focuses on providing a serene and secure setting to facilitate your treatment.

Many individuals begin to notice an improvement in their symptoms within the first few weeks of starting SPRAVATO® therapy, with some reporting changes even sooner. However, response times can vary from person to person, so it is important to maintain open communication with your healthcare provider at our clinic to track your progress.

We’ve got you covered with detailed information about how SPRAVATO® works, what to expect during treatment, and if it’s right for you. Click here to learn more about SPRAVATO®.