Under that approval, patients had to take an oral antidepressant alongside Spravato.
Now, the nasal spray can be used on its own.
How Effective Is Spravato?
Photo Illustration by Amelia Manley for Verywell Health; Spravato
In the clinical trials that supported the original Spravato approval, researchers compared esketamine to an oral antidepressant.
Those requirements can make it more difficult to access Spravato.
Sanacora said that the Spravato efficacy data had to clear a high bar to win FDA approval.
However, managing treatment-resistant depression often requires forms of therapy beyond medication.
When people are involved in these clinical trials, they get a tremendous amount of mental health support.
They get very close follow-up and very thorough evaluations by mental health professionals, Sanacora said.
How Long Does the Treatment Last?
In the following four weeks, the dosing is reduced to once per week.
But many people return for maintenance doses once a week to once every few weeks for years.
I would say the majority of patients feel that they need to come in at some interval.
That interval can change because life is dynamic, and life circumstances change.
That’s part of the beauty of the treatmentit really is tailored to each individual and their needs."
How Safe Is Spravato?
REMS requires patients to administer Spravato at a clinic in the presence of a physician.
We really know a tremendous amount about it, Sanacora said.
Ketamine is a psychoactive drug that can cause acute changes in cognition and perception.
Malina said that having healthcare providers available to support patients through treatment minimizes safety risks.
Ketamine in general has psychedelic properties.
They may offer ketamine in low-dose intravenous infusions or oral tablets, in addition to Spravato.
In our center, weve seen really incredible results with Spravato and ketamine in general, Malina said.
But those drugs also come with the potential for abuse and cognitive effects that require higher levels of care.
Its an exciting time to be in the field, but theres so much to be considered.
2021;82(2):20m13699.
doi:10.4088/JCP.20m13699
Johnson & Johnson.Janssen announces results of esketamine nasal spray phase 3 study in patients with treatment-resistant depression.
Johnson & Johnson.Rationale for Use of SPRAVATO in conjunction with oral antidepressant during phase 3 studies.
