The U.S. Food and Drug Administration on Tuesday said it approved a Johnson & Johnson nasal spray antidepressant for people resistant to other treatments.
But it placed restrictions on use of the drug, which it warned could be misused and abused.
The OK of nasal spray esketamine marks the first new type of treatment for depression in more than 30 years and has raised hopes for its relatively fast action and ability to treat some otherwise unreachable patients.
Esketamine would be sold under the brand name Spravato and is a chemical mirror image of anesthetic ketamine — which also is abused as a recreational party drug and goes by the street nickname “Special K.”
To prevent abuse, patients must take the drug in a doctor’s office or medical facility and cannot take it home.
Currently available anti-depressants such as Eli Lilly’s Prozac work on neurotransmitters such as serotonin and norepinephrine, but most drugs take at least four weeks to show effect and fail to produce an adequate response in about 30 percent to 40 percent of patients with a major depressive disorder.
“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, global head of J&J’s Janssen’s research and development.
Spravato has been touted as an asset with blockbuster potential. It is expected to improve investor sentiment toward the growth prospects of J&J’s pharma unit Janssen, as its top-selling rheumatoid arthritis drug Remicade faces increased competition from cheaper biosimilars.
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The treatment carries a boxed warning — FDA’s harshest — flagging the risk for sedation and difficulty with attention, judgment and thinking, abuse and misuse, and suicidal thoughts after administration of the drug.
Spravato is absorbed by the lining of the nasal passages and into the blood stream and will be used along with a newly prescribed oral antidepressant, Johnson & Johnson said in a statement.