Spravato for Treatment-Resistant Severe Depression (Update)

April 23, 2019

Esketamine comes with close supervision requirements. 800 clinics have already been approved and dispensed initial applications. 

The FDA has approved Spravato (esketamine, Janssen) for treatment of treatment-resistant depression in adults. It is a nasal spray that must be used in conjunction with an oral antidepressant in a certified physician's office or clinic. Esketamine is the s-enantiomer of ketamine.

The patient self-administers the esketamine spray under supervision, with treatments twice a week for four weeks. 

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The wholesale price for Spravato is reported to be between $2,360 and $3,540 per course of treatment. 

As of April 16th, CNBC reports that nearly 800 health centers have been approved to administer the ketamine-like drug, with initial patients already recieving and benefitting from treatment. 

Pharmacies seeking certification to receive and fufill Spravato prescriptions may fill out the Spravato REMS Pharmacy Enrollment Form, and send via fax at 1-877-778-0091.

Online enrollment is unavailable at the time of this release. Full Spravato REMS Pharmacy Enrollment information can be accessed here.

Page 2: Prescribing Information

Prescribing Information 

Spravato (esketamine, Janssen Pharmaceuticals)

Indications: NDMA recetor antagonist indicated, in conjunction with oral antidepressant, for treatment-resistant depression

Dosage /REMS: intransal application under supervision of a healthcare provider

  • patients are to remain under healthcare supervision for at least two hours after receiving the nasal application

Contraindications:

  • Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial and peripheral arterial vessels) or arteriovenous malformation

  • Intracerebral hemorrhage.

  • Hypersensitivity to esketamine, ketamine, or any of the excipients.

Full Prescribing Information