FDA approves esketamine, drug to treat severe depression
The Food and Drug Administration recently approved a fast-acting nasal spray to treat severe depression. But some people have raised concerns about the drug’s close relationship to ketamine, a hallucinogenic street drug nicknamed “Special K."
Esketamine, a drug administered as a nasal spray under the brand name Spravato, was developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. In studies, it relieved symptoms of treatment-resistant depression within 24 hours for patients who have tried at least two other antidepressants without success. Other antidepressants often take weeks to be effective.
The FDA approved ketamine injections under the brand name Ketalar in 1970. They later designated esketamine as a “breakthrough therapy” in 2013 and expedited its review and approval. But esketamine’s tie to the street drug ketamine has people worried about its side effects.
Joseph Beck, MD, a psychiatrist at UChicago Medicine Ingalls Memorial, said all forms of ketamine can cause sedation, dissociation and hallucinations in up to 75 percent of users. According to the FDA, the Spravato labeling cautions that patients are at risk for “sedation and difficulty with attention, judgment and thinking (dissociation), abuse and misuse, and suicidal thoughts and behaviors after administration of the drug.”
The new nasal spray will not be available commercially, but rather used in treatment centers under the supervision of medical professionals. Patients must be monitored by a health care provider for at least two hours after receiving their Spravato dose. The FDA approved the drug under the condition it would be administered in conjunction with an oral antidepressant.
The FDA will also require both the prescriber and the patient to sign a “Patient Enrollment Form” that clearly states the patient understands the side effects and should not drive or operate heavy machinery on the same day they take the drug.
Beck said that forms of ketamine are already being used to treat depression. “They’ve re-patented an ancient drug used in anesthesia,” Beck said. “There are generic alternatives because ketamine is an old drug. What’s new is the approval of the delivery system.”
Beck said, given research about the use of ketamine, esketamine could be an effective treatment. He added there have been long-lasting responses in patients to the initial use of ketamine, administered by injection. “People could stay well for months,” he said. The nasal spray esketamine is novel because of its pharmacodynamics and kinetc differences to other treatments.