The drug is to treat severe symptoms of depression, including adults with treatment-resistant depression (TRD).
There's a new ally in the ongoing battle against depression that doctors say works faster and more efficiently than previous drugs.
People who are now struggling with MDD are considered to have TRD if they have not responded adequately to at least 2 different antidepressants of adequate dose and duration in the current depressive episode. And that is probably why studies show it can often help people with major depressive disorder who haven't been helped by other drugs.
But esketamine presents some challenges because of its similarities to ketamine.
Earlier this year, an FDA advisory body voted 14-2 in favour of the Johnson & Johnson drug, based on three short-term clinical trials and one longer-term maintenance-of-effect trial. Given in low doses through infusions, he says Ketamine is safe and effective.
Dr. Murphy also says the approval of "Spravato" could be revolutionary for those who suffer from depression, and hopes Ketamine treatments become more widespread.
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According to the FDA, trials of the spray demonstrated a "statistically significant effect compared to placebo on the severity of depression" with some effects noted within two days.
Unlike ketamine, psilocybin and MDMA have no legal medical use. Johnson & Johnson is hopeful that this drug will be approved by hundreds of centers within the first year. He said the approval legitimizes the approach he and other doctors have been taking. Because of this, patient are required to be monitored by a health care professional for at least two hours after Spravato is administered and will be used in connection with an oral antidepressant, the FDA said.
Spravato was developed by a group of researchers who discovered that ketamine has a rapid antidepressant effect.
The Food and Drug Administration on Tuesday cleared the inhalable drug for patients who have failed to find relief with older antidepressants. At least 150 clinics around the US provide treatment with various forms of the drug, which is available as a low-priced generic. It did not, however, reveal the drug's list price.
Johnson & Johnson said the wholesale cost of each Esketamine treatment will range from $590 to $885, depending on the dose.
Although it was approved, the new medication has many risks and is therefore required to be used only under the direct supervision of a physician.