The FDA’s approval of Spravato (esketamine) offers hope to millions living with hard-to-treat depression.
March 5, 2019—The FDA has approved Johnson & Johnson’s Spravato for treatment-resistant depression. The drug represents the first new major pharmaceutical advancement in the treatment of depression since Prozac was introduced in the late 1980s.
“This is potentially a game changer for millions of people,” said Dr. Dennis Charney, M.D., dean of the Icahn School of Medicine at Mount Sinai in New York. “It offers a lot of hope.”
According to the World Health Organization, depression is leading cause of disability worldwide, and it affects over 16 million Americans each year. Many of them suffer from treatment-resistant depression, which increases the risk of suicidal ideation, hospitalization and self-harm, notes the FDA.
“[Spravato] has the potential to change the treatment paradigm and offer new hope to the estimated one-third of people with major depressive disorder who have not responded to existing therapies,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC.
While Prozac and other similar medications work by targeting the neurotransmitter serotonin, Spravato (chemical name esketamine) targets glutamate, levels of which are depleted in people with major depressive disorder. This new drug is chemically related to ketamine, the 90s “party drug” known by the street name Special K.
While esketamine is chemically similar to ketamine, it is not the same. Rather, the two are essentially “chemical cousins.” While these molecules are similar to one another, the new drug is actually more potent, and it has less unpleasant dissociative effects. It is also easier to administer. Spravato will be available as a nasal spray, whereas traditional ketamine is given intravenously and at a higher dose.
Spravato is currently approved for treatment-resistant depression, and phase III clinical trials are being conducted regarding its effictiveness on those with major depressive disorder who are at high risk of becoming suicidal. In the coming years, Janssen (a subsidiary of Johnson & Johnson) may also investigate Spravato’s efficacy in regard to other mental health conditions, such as bipolar and schizophrenia, but the company has made no formal announcement at this time.
Quick facts on Spravato:
a new option for treatment-resistant depression is available as a nasal spray
used in conjunction with an oral antidepressant
only for people who have tried at least two other antidepressants
administered only in a certified doctor’s office or clinic
taken once or twice a week for the first month, then weekly
requires monitoring for at least two hours after taking the drug
use prohibits driving and operating heavy machinery for the rest of the day
costs between $590 and $885, before insurance and rebates
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