On January 21, 2025, the FDA approved Spravato® nasal spray as the first and only monotherapy for adults living with TRD. The new label expansion will offer greater flexibility in treatment plans, enabling providers to discontinue other medications that are ineffective, expensive or cause side effects. Looking for more information on Spravato® or wondering what this update could mean for the people you serve? Here are four things you should know.
What is Spravato®?
Spravato® is an FDA-approved nasal spray indicated for the treatment of TRD in adults and for the treatment of depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior. The way that Spravato® works is not completely understood, but it is thought to be through the NMDA (N-methyl-D-aspartate) receptor antagonism, which affects GABA and glutamate, the most abundant neurotransmitter in the brain. Patients generally experience a quick onset of action, with results occurring within a few days or weeks.¹
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Potential side effects of Spravato®
Spravato® has a somewhat favorable side effect profile in that its side effects aren’t generally associated with the typical side effects patients experience with antidepressants, such as weight gain or sexual dysfunction. Most side effects are associated with the administration of Spravato®, such as increased blood pressure, disassociation and sedation. Because of this, Spravato® nasal spray is self-administered by the patient under the direct supervision of a health care provider at a certified Spravato® treatment center.²
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Barriers to offering Spravato®
- Insurance/prior authorization: Coverage for Spravato® varies by insurance or Medicaid provider, with most requiring prior authorization and proof of two failed trials of optimally dosed antidepressant monotherapy. However, with the expanded label approval, the removal of the requirement for concomitant therapy may result in fewer prior authorization requirements.
- Transportation: Patients are advised to wait one full day to drive after receiving Spravato®, requiring them to find alternate transportation on the day of administration.
- Staffing shortages: Administering Spravato® requires a health care professional to monitor the patient receiving Spravato® for two hours after the drug is administered.
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How to offer Spravato® as a treatment option
Spravato® can only be administered in health care settings that are certified through the Spravato® Risk Evaluation and Mitigation Strategy (REMS) program. The certification requirement applies to both the medical offices and/or clinics where Spravato® is administered and the dispensing pharmacy.³
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Most Genoa Healthcare pharmacies are certified in the Spravato® REMS program and can help you and your clinic become certified. Please fill out the form below and we’ll be in touch.
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Have questions about Spravato® or interested in becoming a certified Spravato® treatment center? Fill out for the form below and we’ll be in touch.
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[1]: For information on Spravato® dosing, administration and frequency click here: https://www.spravatohcp.com/dosing-spravato-trd
[2]: For information on potential side effects, click here: https://www.spravato.com/patient-education
[3]: For more information on the certified REMS program, click here: https://www.spravatohcp.com/spravato-rems-certification
