What is Spravato?
Spravato (esketamine) is lifesaving for people with severe depression who do not respond to other depression treatments. About 30 to 40% of patients with depression fail to respond to first-line treatments including oral antidepressant medications of all classes (selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), etc.) and/or psychotherapy. We can offer Spravato treatment for patients whose depression has not responded to other therapies, described as the “Breakthrough in Depression Treatment in 50 Years.” Spravato is now an FDA approved treatment. NeuroPsych Wellness Center, PC is proud to have helped prove the efficacy of this breakthrough treatment and to be one of the first to use the newly available groundbreaking treatment.
Our experience is unparalleled as our clinicians administer treatment and monitor patients not technicians. Spravato is the new brand name for esketamine that comes in ready to use nasal spray. It was approved by the FDA in March 2019 for patients with treatment resistant depression, in conjunction with an oral antidepressant. The FDA requires that Spravato treatment takes place only at approved treatment centers. By law, it cannot be prescribed for home use. The treatment is done as an outpatient in the privacy of our offices. The reason antidepressants may not work for everyone is that they target just a few of the brain’s chemical transmitter systems, such as serotonin, norepinephrine, and dopamine.
Spravato is NMDA receptor antagonist for treatment resistant depression. NMDA receptors modulate glutamate. Spravato treatment at NeuroPsych Wellness Center, PC is covered by your insurance. Spravato treatment at our clinic is provided and monitored by Clinicians not technicians.
Is there a difference between SPRAVATO® (esketamine) Nasal Spray CIII and a ketamine infusion?
SPRAVATO® (esketamine) CIII nasal spray is the S-enantiomer of racemic ketamine. SPRAVATO® is an FDA-approved nasal spray for treatment-resistant depression (TRD) and major depressive disorder (MDD) with acute suicidal ideation or behavior (MDSI). Ketamine has not been approved by the FDA to treat depression. Both SPRAVATO® and ketamine are Schedule III controlled substances under the U.S. Controlled Substances Act.
Are there samples of SPRAVATO®?
There are no samples of SPRAVATO® available — in accordance with federal guidelines — which prohibit the distribution of samples of class III medications.
How can I receive SPRAVATO®?
SPRAVATO® has a controlled distribution network that ensures SPRAVATO® is distributed only to certified healthcare settings and certified pharmacies. SPRAVATO® is not to be delivered directly to patients. REMS-certified pharmacies will follow standard acquisition protocols via full-line wholesalers and dispense SPRAVATO® to REMS-certified treatment centers. REMS-certified healthcare centers can purchase SPRAVATO® directly from specialty distributors. To learn more about REMS certification, call 703-865-8686.
Can SPRAVATO® be taken with other depression medications?
SPRAVATO® should be administered in conjunction with an oral antidepressant (AD). In TRD, the new open-label oral AD initiated during Study 1 (short-term) was an SSRI in 32% of patients and an SNRI in 68% of patients. In MDSI trials for adults with MDSI, all patients received comprehensive standard-of-care treatment, including an initial inpatient hospitalization and a newly initiated or optimized oral AD therapy as determined by the investigator.
SSRI=selective serotonin reuptake inhibitor.
SNRI=serotonin and norepinephrine reuptake inhibitor.
How much does SPRAVATO® cost?
The cost of SPRAVATO® to your patients is dependent on their insurance plan. SPRAVATO with Me offers access and affordability options for your patients, depending on their plan.
How can patients get access to SPRAVATO®?
SPRAVATO® is only administered in a medically supervised healthcare setting that is certified under the SPRAVATO® REMS. SPRAVATO® is not to be delivered directly to patients.
SPRAVATO® is a nasal spray that is administered under the supervision of a healthcare provider. Certified SPRAVATO® treatment centers will need to provide the infrastructure and operational support to prepare and monitor patients during self-administration and prior to release from the treatment center.
If you are interested in establishing your practice as a treatment center for SPRAVATO®, you must enroll in the SPRAVATO® REMS and become certified.
To learn more about REMS certification, visit www.neuropsych4u.com or call 703-865-8686.
What happens if a patient misses a dose of SPRAVATO®?
If a patient misses treatment sessions, provided there is no worsening of their depressive symptoms, the patient should continue the current dosing schedule.
For patients who miss treatment sessions during maintenance treatment and have worsening of depression symptoms, per clinical judgment, consider returning to the previous dosing schedule (if doses missed during weekly dosing, revert to twice-weekly dosing).
Can patients pick up SPRAVATO® at their pharmacy and self-administer at home?
No, under the REMS, SPRAVATO® must be administered in a certified healthcare setting. Due to the possibility of delayed or prolonged sedation or dissociation in some cases, patients should be monitored by a healthcare provider for at least 2 hours following each treatment session, or until the clinician determines the patient is safe to leave.
SPRAVATO® is also administered under REMS due to the potential for abuse and misuse. Consider the risks and benefits of prescribing SPRAVATO® prior to using it in patients at higher risk of abuse. Monitor patients for signs and symptoms of abuse and misuse.
Does SPRAVATO® prevent suicide?
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®.
How soon can a patient drive after taking SPRAVATO®?
Caution patients that SPRAVATO® may impair their ability to drive or operate machinery. Instruct patients not to engage in potentially hazardous activities requiring complete mental alertness and motor coordination, such as driving a motor vehicle or operating machinery, until the next day after a restful sleep.
- What is Spravato?
- Getting Started on Spravato
- Patient Stories
- Proven effective for depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions (MDSI).
Induction Phase Weeks 1 to 4:
Day 1 starting dose: 56 mg Administer twice per week
Subsequent doses: 56 mg or 84 mg individualized to each patient.
Maintenance Phase Weeks 5 to 8:
Administer once weekly 56 mg or 84 mg.
Week 9 and after:
Administer every 2 weeks or once weekly 56 mg or 84 mg.
Dosing frequency is individualized to each patient.
It’s important for each patient to continue their treatment with their treating Psychiatrist and Therapist while receiving Spravato Treatment for better results. Our treatment team will co-ordinate your treatment plan about Spravato with your Psychiatrist and Psychotherapist ongoing.
