New drug approved for treatment resistant depression (TRD)
We’ve been following Spravato since before it was submitted to the FDA for approval.June 26, 2019
Drug: Spravato® (esketamine) nasal spray
Manufacturer: Janssen Research & Development, LLC, a pharmaceutical company of Johnson & Johnson
Condition: Treatment-resistant depression (TRD)
Major depressive disorder affects almost 300 million people of all ages, globally.¹ About one-third of patients diagnosed with major depressive disorder do not respond to currently available treatments.³ Treatment-resistant depression (TRD) is diagnosed in patients who have not responded to at least two different antidepressant treatments for their current depressive episode. For most people with depression, taking antidepressants or going to psychological counseling (psychotherapy) eases depression symptoms. With TRD, however, standard treatments are not enough.³
Current treatments for treatment resistant depression³:
- Allowing more time for medications to become effective
- Increasing medication dosage, if indicated
- Switching antidepressants
- Adding another type of antidepressant
- Adding medication used for other conditions (augmentation)
- Consider the cytochrome P450 (CYP450) genotyping test to check for specific genes that indicate how well the body can process (metabolize) a medication
- Psychotherapy: Speaking with a trained mental health professional who helps patients talk about moods and behaviors.
- Support groups: Talking with other people who also have depression may help patients feel less alone and more informed about their illness and its treatments.
- Neurostimulation: Also called spinal cord stimulation, is the safe delivery of low voltage electricity to the dorsal column or peripheral nerves.5 It’s an option for people who have tried a variety of antidepressants that didn’t work, only partly worked, or stopped working.
In September 2019, Janssen submitted a new drug application (NDA) to the Food and Drug Administration (FDA) for Spravato (esketamine) nasal spray for treatment-resistant depression.
It works differently than currently available therapies for major depressive disorder. It’s a nasal spray and it is thought to help restore synaptic connections in the brain cells of people with major depressive disorder.
Spravato nasal spray can be self-administered by patients, but because of the risk of sedation and dissociation, must be given under the supervision of a health care professional.²
The U.S. Food and Drug Administration (FDA) had granted Breakthrough Therapy Designations for esketamine to be used in treatment-resistant depression and major depressive disorder with imminent risk of suicide. That sped up the review process.
Approved: March 6, 2019
Benefit: Spravato will impact the medical benefit as administration must be given under the supervision of a health care professional.
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