The Nulton Diagnositc & Treatment Center (NDTC) is now REMS Certified and Ready to Provide a Treatment Option in two Subpopulations of Adults With Major Depressive Disorder (MDD)
We are now Risk Evaluation and Mitigation Strategy (REMS)–certified to provide SPRAVATO® (esketamine) CIII, a nasal spray approved for use, in conjunction with an oral antidepressant, to treat treatment-resistant depression (TRD) in adults and depressive symptoms in adults with MDD with acute suicidal ideation or behavior.
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.
Because of the risks for sedation, dissociation, abuse and misuse, and suicidal thoughts and behaviors, SPRAVATO® carries a Boxed WARNING and is available only through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO® can be administered only at healthcare settings certified in the SPRAVATO® REMS Program and to patients enrolled in the program. SPRAVATO® is never dispensed directly to a patient for home use.
The medical staff at our certified treatment center are trained to prescribe, dispense, and administer SPRAVATO®, and we have established processes and procedures in accordance with the REMS. A healthcare provider will provide direct medical supervision as the patient self-administers SPRAVATO® and will monitor every patient after every dose for at least two hours for resolution of sedation and dissociation and changes in vital signs.
SPRAVATO® must never be dispensed directly to a patient for home use. Additionally, all patients require transportation from NDTC following the observation period, as they should not drive or operate machinery until the day after a treatment session, following a restful sleep.
At NDTC, we understand that finding an appropriate treatment option for these patients can be complex. We are committed to partnering with your practice to provide a well-coordinated treatment experience with SPRAVATO® for appropriate adult patients.
Our treatment center will carry out benefits investigation to ensure that you and your patients are aware of coverage and costs prior to SPRAVATO® treatment.
To learn more about our treatment center and how we can work together to provide appropriate adult patients with SPRAVATO®, please contact us at spravato@nulton.com
About SPRAVATO®
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.1
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® PATIENT VIDEO: NICOLE’S STORY
About the SPRAVATO® Risk Evaluation & Mitigation Strategy (REMS)
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.
