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Newly Approved Nasal Spray Made Available for Veterans
The Department of Veterans Affairs (VA) recently announced that its health care providers will be able to offer veterans the newly approved nasal spray for treatment-resistant depression.
According to the VA, Spravato (esketamine) nasal spray will be made available to veterans based on an individual basis combined with clinical assessments. The treatment will be available through a restricted distribution system under an US Food and Drug Administration (FDA)-approved Risk Evaluation and Mitigation Strategy (REMS). Health care professionals will utilize the REMS program to mitigate the risks of serious adverse outcomes and the potential abuse and misuse of the treatment.
Veterans selected to receive Spravato will self-administer the treatment under direct observation of a health care provider in a certified medical facility. The veteran will then be monitored for at least two hours after receiving their dose by a health care provider. The VA has noted that Spravato cannot be dispensed directly to any veteran for use at home.
VA health care providers will monitor veterans for serious adverse outcomes. These adverse outcomes include sedation and difficulty with attention, judgment and thinking (dissociation), abuse and misuse, worsening of depression, and suicidal thoughts and behaviors.
“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 statement. “It reflects our commitment to seek new ways to provide the best health care available for our nation’s veterans.”
Spravato was originally approved by the FDA on March 5, 2019 for use in conjunction with an oral antidepressant for the treatment of treatment-resistant depression in adults. —Julie Gould