It will be marketed under the brand name Spravato.
The drug will cost $590 for a 56mg dose and $885 for an 84mg dose, and will only be available to people who have failed with at least two other antidepressant therapies. Esketamine and ketamine work by targeting glutamate, unlike now used antidepressants that target serotonin, and doctors were already using ketamine off-label to treat depression, according to the AP.
Prozac therapy can take weeks or months to become effective, but Spravato has an nearly immediate effect as it alters the neurotransmitter glutamate, according to researchers.
"There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition", said Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. The nasal spray is a mirror image of the chemical "anesthetic ketamine", popular as a recreational party drug, which is known locally as the "Special K". As part of UCLA's Depression Grand Challenge project, scientists are examining how ketamine might work in the treatment of depression and which patients might respond better to treatment. The first month of treatment can range in price from $4,720 to $6,785, with subsequent monthly costs ranging from $2,360 to $3,540 before insurance discounts and rebates.
Two of the other three short-term trials did not meet pre-determined statistical tests for effectiveness.
United States pulls remaining diplomats out of Venezuelan embassies as crisis worsens
The country has been crippled by a five-day power outage that has plunged people into darkness and left food and water scarce. However, Pomeo said during the Monday press briefing that the United States has aided Venezuela to be a democratic country.
The FDA approved the drug with restrictions to address those concerns.
The medicine will be available with a warning label that in some people, it can increase suicidal thoughts during the first few months of treatment or if the dosage is changed. "We have carefully reviewed the drug, and it met our criteria to get approved for depression treatments". FDA approval was granted after "statistically significant" effects were observed in a trial. This is due to strong potential for abuse and misuse of the drug, as it contains a compound similar to street-drug ketamine.
The nasal spray, from Johnson & Johnson, has been approved for use by the US Food and Drug Administration (FDA) and is the first treatment to tackle depression in a new way for decades.
Treatments will be administered at doctor's offices or clinics, where patients will self medicate with the spray and then be monitored for at least two hours.
"Substantially different agents are only rarely appearing from pharmaceutical companies or other laboratories", said Dr. Paul Summergrad, a psychiatrist at Tufts University.