March 19, 2019, 05:39:00 PM Printable Version WASHINGTON — Today the U.S. Department of Veterans Affairs (VA) announced its health care providers will now be able to offer the newly approved Spravato nasal spray for treatment-resistant depression. The treatment will be made available to Veterans based on their individual medical needs combined with providers’ clinical assessments. The move follows the March 5 Food and Drug Administration (FDA) approval of Spravato (esketamine) nasal spray. Spravato was approved for use in conjunction with an oral antidepressant for the treatment of treatment-resistant depression in adults. “We’re pleased to be able to expand options for Veterans with depression who have not responded to other treatments,” said VA Secretary Robert Wilkie. “It reflects our commitment to seek new ways to provide the best health care available for our nation’s Veterans.” Spravato will be available through a restricted distribution system under an FDA-approved Risk Evaluation and Mitigation Strategy (REMS). The purpose of the REMS is to mitigate the risks of serious adverse outcomes and the potential abuse and misuse of Spravato. VA health care providers will monitor Veterans for serious adverse outcomes, such as sedation and difficulty with attention, judgment and thinking (dissociation), abuse and misuse, worsening of depression and suicidal thoughts and behaviors. Veterans will self-administer Spravato nasal spray under the direct observation of a health care provider in a certified medical facility, and then must be monitored by a health care provider for at least two hours after receiving their dose. Spravato cannot be dispensed directly to Veterans for use at home. For additional information on access to Mental Health Support for Veterans, visit VA Mental Health. Veterans in immediate crisis may call the Veterans Crisis Line at 800-273-8255 and press 1, text to 838255 or chat online at Veterans Crisis Line. ###
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For adults with treatment-resistant depression
For depressivesymptoms in adultswith MDD with suicidal thoughts or actions
For Immediate Release: March 05, 2019 Español The U.S. Food and Drug Administration today approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression). Because of the risk of serious adverse outcomes resulting from sedation and dissociation caused by Spravato administration, and the potential for abuse and misuse of the drug, it is only available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy (REMS). "There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition," said Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. "Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA’s drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment. Because of safety concerns, the drug will only be available through a restricted distribution system and it must be administered in a certified medical office where the health care provider can monitor the patient." Patients with major depressive disorder who, despite trying at least two antidepressant treatments given at adequate doses for an adequate duration in the current episode, have not responded to treatment are considered to have treatment-resistant depression. The Spravato labeling contains a Boxed Warning that cautions that patients are at risk for sedation and difficulty with attention, judgment and thinking (dissociation), abuse and misuse, and suicidal thoughts and behaviors after administration of the drug. Because of the risk of sedation and dissociation, patients must be monitored by a health care provider for at least two hours after receiving their Spravato dose. The REMS requires the prescriber and the patient to both sign a Patient Enrollment Form that clearly states that the patient understands they should make arrangements to safely leave the health care setting to get home and that the patient should not drive or use heavy machinery for the rest of the day on which they received the drug. Additionally, Spravato must be dispensed with a patient Medication Guide that outlines the drug’s uses and risks. The patient self-administers Spravato nasal spray under the supervision of a health care provider in a certified doctor’s office or clinic, and the spray cannot be taken home. The health care provider will instruct the patient on how to operate the nasal spray device. During and after each use of the nasal spray device, the health care provider will check the patient and determine when the patient is ready to leave. The efficacy of Spravato was evaluated in three short-term (four-week) clinical trials and one longer-term maintenance-of-effect trial. In the three short-term studies, patients were randomized to receive Spravato or a placebo nasal spray. In light of the serious nature of treatment-resistant depression and the need for patients to receive some form of treatment, all patients in these studies started a new oral antidepressant at the time of randomization and the new antidepressant was continued throughout the trials. The primary efficacy measure was the change from baseline on a scale used to assess the severity of depressive symptoms. In one of the short-term studies, Spravato nasal spray demonstrated statistically significant effect compared to placebo on the severity of depression, and some effect was seen within two days. The two other short-term trials did not meet the pre-specified statistical tests for demonstrating effectiveness. In the longer-term maintenance-of-effect trial, patients in stable remission or with stable response who continued treatment with Spravato plus an oral antidepressant experienced a statistically significantly longer time to relapse of depressive symptoms than patients on placebo nasal spray plus an oral antidepressant. 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. Patients with unstable or poorly controlled hypertension or pre-existing aneurysmal vascular disorders may be at increased risk for adverse cardiovascular or cerebrovascular effects. Spravato may impair attention, judgment, thinking, reaction speed and motor skills. Patients should not drive or operate machinery until the next day after a restful sleep. Spravato may cause fetal harm and women of reproductive potential should consider pregnancy planning and prevention; women should not breastfeed while being treated. Esketamine is the s-enantiomer of ketamine. Ketamine is a mixture of two enantiomers (mirror image molecules). This is the first FDA approval of esketamine for any use. The FDA approved ketamine (Ketalar) in 1970. The FDA granted this application Fast Track and Breakthrough Therapy designations. The FDA granted the approval of Spravato to Janssen Pharmaceuticals, Inc. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. Related Information###
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