FDA Approves New Depression Drug

The U.S. Food and Drug Administration has approved a new drug to treat depression that is derived from an old and widely used anesthetic, ketamine. The new nasal spray treatment, called esketamine, was developed by Janssen Pharmaceuticals Inc., a branch of Johnson & Johnson, and will be marketed under the name Spravato. According to Janssen, the wholesale cost for a course of treatment will be between $2,360 and $3,540.

Patients prescribed the medication will take the newly approved drug twice a week, for four weeks, with boosters as needed. This will be in addition to one of the commonly used oral antidepressants. The drug is intended for patients that have not responded positively to other currently available treatments. Out of the estimated 16 million American adults living with depression, as many as one-quarter gain little or no benefit from available treatments.

Under the FDA’s requirements, the doses must be taken in a doctor’s office or clinic and the patients must be monitored during that time. This is because ketamine is known to cause out-of-body and hallucinogenic sensations when administered. While esketamine’s side effects are thought to be less dramatic, safety monitoring for two hours is required. It is also advised that patients refrain from driving on the day of the treatment.

In the clinical trials paid for and performed by Janssen, the results were mixed. In one month-long study, those on esketamine performed better statistically than those on placebo. In two others trials, there was not statistical difference between the drug and the placebo treatment. The FDA typically requires a drug to succeed in two short-term trials before it is approved, but in this case, the agency accepted the results of a trial to study relapse in people who did well on the drug as the second trial.