FDA approves Johnson & Johnson's Fast-Acting Depression drug for quick relief from mental depression is undoubtedly a great success for the acute patients. Janssen said in a statement that this spray of Spravato is a "potential therapy for adults living with treatment-resistant depression".
Scientists say it is the first new drug for 35 years for depression, with no major breakthroughs since the launch of treatments like Prozac in the 1980s.
The new treatment, which is called Spravato (drug name esketamine) is a nasal spray that is meant to influence the NMDA receptor in the brain that has been linked to depression.
During clinical trials, Spravato was found to relieve depression symptoms within 24 hours in some patients, said Janssen spokesman Greg Panico.
Esketamine is the s-enantiomer of ketamine.
The US Food and Drug Administration approved Johnson & Johnson's new drug, which is believed to have fewer negative side effects than ketamine.
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The drug's active ingredient is related to the club drug and anesthetic ketamine.
That means about 5 million of the 16 million people in the USA with major depression might benefit from esketamine, said Courtney Billington, president of Janssen Neuroscience, a unit of Johnson & Johnson. Still, ketamine has always been explored as a potential treatment for depression due to its ability to relieve symptoms within hours. Even so, doctors can legally prescribe it for off-label medical uses.
"Substantially different agents are only rarely appearing from pharmaceutical companies or other laboratories", said Dr. Paul Summergrad, a psychiatrist at Tufts University.
The drug will only be given by accredited specialists who must monitor patients for at least two hours after administration, due to its trippy, disorienting effects. Patients often pay hundreds or thousands of dollars for intravenous infusions of the drug over several weeks or months. At least 150 clinics around the US provide treatment with various forms of the drug, which is available as a low-priced generic.
Spravato was developed by a group of researchers who discovered that ketamine has a rapid antidepressant effect. Johnson & Johnson is hopeful that this drug will be approved by hundreds of centers within the first year.
But he hopes that doctors who are now using ketamine continue to do so. Presently, this medicine is likely to cost between the ranges of $4,720 to $6,785 per month, however, Johnson & Johnson has assured that soon the prices of Spravato will decline to $2,360 to $3,540 per month.