The U.S. Department of Veterans Affairs announced today that the newly FDA-approved esketamine nasal spray will be available to veterans with treatment-resistant depression.
“We’re pleased to be able to expand options for Veterans with depression who have not responded to other treatments,” VA Secretary Robert Wilkie, said in a press release. “It reflects our commitment to seek new ways to provide the best health care available for our nation’s Veterans.”
Treatment eligibility for esketamine nasal spray (Spravato, Janssen) is based on clinical assessment and individual medical needs.
Patients will self-administer the nasal spray under observation at certified medical facilities; the spray cannot be dispensed for use at home. After receiving their dose, patients will undergo monitoring for at least 2 hours for the occurrence of adverse events such as sedation; trouble with attention, judgment and thinking; abuse and misuse; worsening depression; and suicidal thoughts and behaviors, according to the release.
The FDA approved esketamine nasal spray on March 5. Due to safety concerns, the spray will only be available through a restricted distribution system under a Risk Evaluation and Mitigation Strategy (REMS).