The FDA recently approved Esketamine, a medication which is available from Janssen Neuroscience under the brand name Spravato.
Spravato is available only through a restricted program known as the Spravato REMS (Risk Evaluation and Mitigation Strategy) because of serious adverse outcomes that can be associated with the use of the medication including sedation, dissociation, abuse, misuse, and elevated blood pressure.
Spravato is FDA approved for adult patients (18 years or older) to be used in combination with another antidepressant medication for patients who suffer from Treatment Resistant Depression. It is administered as a nasal spray twice weekly for the first 4 weeks of treatment, then once weekly for 3 weeks, then once every 1-2 weeks thereafter.
This is a medication that can only be given in a clinic setting where patients can be medically monitored for at least 2 hours after administration. This requirement is part of the Spravato REMS program mentioned above which is in place due to the following possible side effects:
Risk of sedation and dissociation –
In clinical trials, 49%-61% of patients developed sedation and 0.3% of patients experienced a loss of consciousness. Dissociative or perceptual changes occurred in 61% – 75% of patients. The effect typically starts about 40 minutes after administration. Cognitive impairment typically clears in about 2 hours, but sleepiness may take 4 hours to clear. Patients should not drive or engage in any other potentially dangerous activities until the following day after a normal period of sleep.
Potential for abuse and misuse –
Spravato is a schedule III controlled substance, individuals with a history of substance abuse or dependence may be a greater risk for abuse and misuse of this medication.
Risk for an increase in blood pressure –
Blood pressure typically peaks about 40 minutes after administration. Approximately 8%-17% of patients experienced an increase of more than 40 mmHg in systolic BP and/or 25 mmHG in diastolic BP in the first 1.5 hours after administration. As a general rule, Spravato therapy may be delayed if pre-treatment BP is >140/90.
The most common side effects experienced by patients treated with Spravato in the clinical trials were disassociation, dizziness, nausea, sedation, vertigo, decreased feeling or sensitivity (hypoesthesia), anxiety, lethargy, increased blood pressure, vomiting and feeling drunk.
Based on the requirements of the Spravato REMS Program, Indiana Health Group is not offering this therapy at our office at the present time. Although we are interested in this novel form of treatment, at present time we do not have the space or additional medical staff that would be necessary to safely and effectively provide this form of treatment in compliance with the requirements of the program. We will continue to evaluate this and will determine if we may be able to offer this treatment at our office at some point in the future.
For now, we will make every effort to assist interested patients who may be appropriate candidates for this treatment to other local facilities who are able to provide this as we become of aware of them.
Indiana Health Group