FDA Approves ‘Spravato’ Nasal Spray As A Standalone Depression Treatment

Educating people about the importance of mental health has been one of the best steps taken. Not so long ago, people did not believe in depression, let alone treat people who have depression correctly. But in recent years we have seen a rise in people who are taking mental health more seriously and working towards making their lives and the people around them better. We also have reached a point where we have medication and treatment options for not just people with depression, but anxiety, BPD, schizophrenia etc. And now FDA has broadened the variety of medicines that are available to people to fight depression! The U.S. Food and Drug Administration (FDA) has broadened its approval for Johnson & Johnson's nasal spray, Spravato esketamine, allowing its use as a monotherapy for severe depression, as announced by the company on Tuesday. This decision marks a significant development in the treatment landscape for individuals with major depressive disorder (MDD).

Spravato was first approved in 2019 to be used with regular antidepressants for people whose depression wasn't getting better with other medicines. It was like an extra treatment that acted almost like a strengthener. Later, it was also approved for people who were thinking about suicide or hurting themselves, because it can work quickly in those urgent situations. Now, doctors can give Spravato by itself, without the person having to take a regular antidepressant pill too. This is a big change and gives doctors and patients more choices.

What This Means For Patients

Experts suggest that with this approval they can now make more personalized medicine for their patients, as we know, everyone takes medicine differently and there is no one-way street for treatment. Doctors now have more ways to treat depression. Some people might do better with just Spravato, while others might still need other medicines too. This personalized way of treating people is really important because everyone's different. This change lets doctors choose the best treatment based on what each person needs, which could help people get better faster.

What Measures Have Been Taken For Patient Safety?

The FDA approved Spravato for use on its own because studies showed it works well in this way. People who used Spravato got better faster than those who didn't in clinical trials. The medicine works on a chemical in the brain called glutamate, which is involved in mood regulation. Spravato is related to ketamine, which is sometimes used illegally as a recreational drug. While both affect glutamate, they are not identical. The clinical trials provided the necessary evidence for the FDA to expand the drug's approved use.

Because Spravato has the potential for misuse and some side effects, it's only available through a special program called a REMS which is the Risk Evaluation and Mitigation Strategy program. The process here is that people who will be given the dose of medicine will be kept under close supervision. The doctors will check on them and their vitals every two hours and see how well the patients were responding to the medicine. This is to make sure it's used safely and to monitor for any adverse reactions, sometimes people don’t respond well to medication, it can also be dangerous if it reacts differently to others. The REMS program is a key part of ensuring patient safety and responsible use of this medication. This controlled distribution system helps to minimize the risk of misuse and ensures proper medical supervision.