There's a new ally in the ongoing battle against depression that doctors say works faster and more efficiently than previous drugs. When it works, the new drug takes effect nearly instantly. But the FDA's approval of esketamine could smooth their path.
Under the brand name Spravato, the drug (which has the chemical name esketamine) will be prescribed to adults who have tried other antidepressant medicines but not benefited from them.
The drug will only be available through a restricted distribution system. The drug's labeling will also warn about the risks of misuse, abuse, and possible suicidal thoughts.
"There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition", said Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, in a press release about the decision.
Esketamine is a relative of ketamine, a powerful anesthetic that has been co-opted as a party drug because it can produce euphoric effects and psychedelic experiences. Because of these concerns, the drug must be taken at a certified health care provider's office and patients are to be monitored for two hours after receiving it, according to. the statement.
Esketamine is derived from the sedative ketamine, which has been used for decades to prepare patients for surgery. Ketamine is a mixture of two enantiomers (mirror image molecules), and this is the first FDA approval of esketamine for any use. For Spravato, however, the agency agreed to consider a withdrawal, or maintenance, study as one of the two positive trials supporting J&J's application.
The Food and Drug Administration on Tuesday cleared the inhalable drug for patients who have failed to find relief with older antidepressants.
A long term study of the drug showed that patients in stable remission taking the drug that continued the treatment were 51 percent less likely to relapse as compared to those who continuously took a placebo with an oral antidepressant.
"My concern is that we don't really how it gets people un-depressed", Mark George, MD, a psychiatrist and neurologist at the Medical University of SC in Charleston, tells Health. The medication will not be dispensed directly to patients for home use.
The license means patients can only receive the treatment called Spravato under medical supervision.
Spravato will cost between $590 and $885 per treatment.
The list price of a drug is not necessarily what patients actually pay.