Spravato (Esketamine) Nasal Spray Approved for Depression
WEDNESDAY, March 6, 2019 -- Spravato (esketamine) nasal spray has been approved to treat adult depression in cases where other antidepressants have failed, the U.S. Food and Drug Administration said Tuesday.
The drug's active ingredient is related to the club drug and anesthetic ketamine.
Citing the possibility of sedation and other potential side effects, the medication's distribution will be strictly controlled, the agency said.
"There has been a longstanding need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition," said Dr. Tiffany Farchione, acting director of the FDA's Division of Psychiatry Products. "Because of safety concerns, the drug will only be available through a restricted distribution system and it must be administered in a certified medical office where the health care provider can monitor the patient."
People are considered to have treatment-resistant depression if they've tried at least two antidepressants without success, the agency said.
Spravato's label includes a boxed warning of users' risk of sedation and difficulty with attention, judgment and thinking; misuse and suicidal thoughts and behaviors. The FDA said users should be monitored by a health care provider for at least two hours after receiving Spravato. In addition, they shouldn't drive or use heavy machinery on the day the drug is given.
Spravato was evaluated in four clinical studies, during which some users took the nasal spray and an oral antidepressant they hadn't tried before. Those who used Spravato showed a significantly longer time to relapse of depressive symptoms than people who took a placebo nasal spray plus an oral antidepressant.
The spray's most common side effects were dissociation, dizziness, nausea, sedation, vertigo, decreased feeling or sensitivity, anxiety, sluggishness, increased blood pressure, vomiting and feeling drunk, the agency said.
More serious side effects could include impaired attention, judgment, thinking, reaction speed and motor skills. Spravato also may harm a developing fetus, and women of childbearing age should consider pregnancy planning, said the FDA, which also said women should not breastfeed while being treated.
Spravato is produced by Janssen Pharmaceuticals, based in Belgium.
The FDA has more about this approval.
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Posted: March 2019