Spravato: New Ketamine Treatment to be Approved by FDA

Last week a committee of the U.S. Food and Drug Administration (FDA) recommended in a 14-2 vote that the agency approve the use of a nasal spray form of esketamine (a specific type of ketamine) for the treatment of treatment-resistant depression and certain other types of depression. Treatment-resistant depression is when clinical depression fails to respond to multiple (at least two) attempts to treat it with at least two different types of medications or psychotherapy over the course of a year or longer. If the FDA ends up approving the drug — and we believe they will — it will offer new hope for people with depression. Ketamine has more recently been prescribed off-label for the treatment of depression at high-priced “ketamine clinics.” Such clinics regularly charge people $650 – $1200 per treatment, with most people needing 6 to 8 treatments to get started. Most insurance won’t cover the cost of this treatment, since depression is not a condition that ketamine is currently approved to treat. The Good News The new drug is named Spravato, an intranasal form of esketamine, and is made by Janssen, a division of Johnson & Johnson. Eventual FDA approval of this type of ketamine treatment would make such treatment far more affordable to more people. The committee determined that Spravato has a favorable benefit-risk profile, after analyzing the safety and efficacy data from five different research studies conducted in patients with treatm...
Source: World of Psychology - Category: Psychiatry & Psychology Authors: Tags: Depression Disorders General Medications Treatment esketamine ketamine for depression Spravato Suicide TRD Treatment Resistant Depression Treatment-resistant Source Type: blogs