FDA Approves Spravato (esketamine) nasal spray to treat treatment-resistant depression in adults, but is only available at certified doctor’s offices and clinics. Treatment-resistant patients are adults with major depressive disorder, who have tried a minimum of two antidepressant treatments at adequate doses for an adequate duration, and have not responded to treatment. Because Spravato poses a serious risk of adverse outcomes resulting from sedation and dissociation, with a high potential for abuse and misuse, Spravato is only available through a restricted distribution system under a Risk Evaluation and Mitgation Strategy (REMS). Patients will only be able to self-administer Spravato nasal spray under the supervision of a health care provider, and the patient must be monitored for at least two hours after receiving their dose.
Read the Full FDA Press Release Here.