The US FDA has approved a unique hybrid drug. The drug in question is a Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant that is meant for the treatment of depression in adults and have not benefitted from the usual anti-depressants they were prescribed. Since Spravato administration has chances being misused and serious adverse outcomes, it will be 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 safey 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."
Only patients who haven’t found at least two anti depressant treatments inadequate are considered for are considered to have treatment-resistant depression.
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.
While this considered a breakthrough for patients suffering from depression, it needs careful execution for its success.
For proper administration, 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.
