The U.S. Food and Drug Administration on Tuesday approved the first nasal spray that will help with treating major depressive disorder.
The spray, known as SPRAVATO, is the first and only monotherapy to treat MDD in adults who have had an inadequate response to at least two oral antidepressants, according to Johnson & Johnson .
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MDD is a common psychiatric disorder. An estimated 21 million adults in the U.S. are living with the disease, and about one-third of adults will not respond to oral antidepressants alone, according to the pharmaceutical company.
“SPRAVATO is now available as a standalone treatment, meaning patients may experience improvements in depressive symptoms as early as 24 hours and at 28 days without the need for daily oral antidepressants,” said Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine.
The drug does have serious adverse outcomes that result in sedation, dissociation, respiratory depression, abuse, and misuse. To facilitate safe use, SPRAVATO is only available through a restricted program called the
“SPRAVATO Risk Evaluation and Mitigation Strategy (REMS) Program.”
The nasal spray targets glutamate, the most abundant excitatory neurotransmitter in the brain, according to Johnson & Johnson.
If you are interested in taking SPRAVATO, it is recommended you talk to your health care provider. When you do, make sure you inform them about your medical conditions. Some conditions could affect the ability of the nasal spray to help you.
You can read a complete list of side effects SPRAVATO could cause and how you can report side effects here.
