If you have been researching advanced options for treating your depression, you may have heard about Spravato. However, before trying any medication, it is natural to want to know the basics. You may be wondering about FDA approval of Spravato, what it is approved to treat, and what that means for your own treatment. Our team can answer your questions. Contact The Neuropsychiatry & TMS Group today to schedule your initial appointment.
Unlike traditional antidepressants that act on serotonin or norepinephrine, Spravato targets a brain chemical called glutamate. This different approach is part of what makes this treatment so promising for people who have not found relief with other therapies.
However, because of how it works in the brain, Spravato can cause temporary dissociative effects. Because of this, you must receive FDA-approved Spravato at a certified clinic, where trained staff can monitor you during and after each session.
The FDA first approved Spravato in March 2019, making it the first new type of antidepressant medication in decades. The availability of a new option that targeted a completely different pathway gave hope to a lot of people who had been struggling with their depression.
The initial approval was specifically for adults seeking more advanced treatment for their depression. Treatment-resistant depression is the clinical term for when someone has tried at least two different antidepressants at the right doses for the right amount of time but has not experienced a meaningful difference in their condition. If that sounds similar to your own situation, you are not alone, and Spravato may be right for you.
In August 2020, the FDA expanded its approval of Spravato to include adults with major depressive disorder who are experiencing suicidal thoughts or actions. This made Spravato one of the few medications specifically approved to help reduce depressive symptoms quickly in people going through a mental health crisis.
This second approval recognized that Spravato can work faster than traditional antidepressants. While most antidepressants take weeks to take effect, some people notice improvements with Spravato within hours or days, which can be critical when someone is in acute distress.
When the FDA approves a medication, it means the agency has reviewed clinical trials and determined that the benefits outweigh the risks for a specific condition. It does not mean the medication is perfect or that it works for everyone, but rather that there is solid evidence that it helps.
For Spravato, the FDA approval process involved thousands of individuals in clinical studies. Researchers looked at how well the medication worked, how safe it was, and what kind of side effects people experienced. The FDA also put specific safety requirements in place, which is why Spravato is only available through a restricted program at certified treatment centers.
FDA approval of Spravato is an important first step, but it does not tell you whether this treatment is suitable for your specific situation. Our team at The Neuropsychiatry & TMS Group can help you learn more about this innovative treatment option.
Contact us today to schedule an appointment if you have been struggling with depression and are wondering whether Spravato can help. We can talk through your history, answer your questions, and determine together whether this may be a good choice for you.
