‘Club drug’ ketamine approved by FDA to treat depression

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By Shamard Charles, M.D.

The U.S. Food and Drug Administration on Tuesday approved esketamine, an experimental nasal spray that delivers the active ingredients of the “club drug” ketamine, as a new treatment for severe depression.

The Johnson & Johnson nasal spray is a variation of the anesthetic ketamine — a pain reliever that was widely abused as a street drug, Special K, in the 1980s and 1990s. The new drug is especially effective in patients who have not benefited from at least two different therapies, also known as treatment-resistant depression, the FDA said.

“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in a statement Tuesday.

Intravenous infusions of ketamine have been shown to help people with severe depression who experience suicidal thoughts, but patients are required to see a provider for treatment. Experts believe that the FDA approval of a quick-acting, easy-to-use spray treatmentis a pivotal moment in the history of mental health therapy.

“This offers an extremely important, new treatment for people suffering with treatment-resistant depression,” Dr. Gerard Sanacora, professor of psychiatry at Yale University and director of the Yale Depression Research Program, told NBC News. “We know that if you don’t respond to the first two standard classes of antidepressants, the chances of you responding to a third or fourth reduces significantly, so this drug which has a completely different mechanism of action is particularly effective for those who have no standard treatment.”

“Drug diversion is a real concern for this class of drug, but the plan is that the drug would be given to providers plan who would then administer the drug to patients on-site,” Sanacora said.

Drugmakers believe the spray can help 30 to 40 percent of patients who don’t respond to antidepressants.

Esketamine, which will be marketed under the trade name, Sparavato is an experimental nasal spray that delivers the active ingredients of the “club drug” ketamine. It was approved as a new treatment for severe depression by the Food and Drug Administration Tuesday.Janssen

The spray works more quickly than other known treatments, such as antidepressants which can take two weeks or more to take effect, showing benefits after only four hours.

“This is extremely important for people who need a drug with a quicker clinical benefit. Esketamine may shorten hospital stay or be used in people who have imminent thoughts or risks of hurting themselves,” Sanacora said.

Depression is very common. Around the world, 300 million people are affected and almost 800,000 commit suicide, according to the World Health Organization. In the United States, from 2013 to 2016, eight percent of American adults had depression in a given 2-week period, and about 80 percent of adults reported at least some difficulty with work, home or social activities because of their depression symptoms, according to the Centers for Disease Control and Prevention.

While not every person with depression thinks about suicide, the lifetime risk of attempting suicide for someone with depression is approximately 20 times that of the general population, even among those who receive adequate treatment.

Warning signs aren’t always obvious, and they may vary from person to person. Some people make their intentions clear, while others keep suicidal thoughts and feelings secret, underscoring the importance of quick and effective treatment.

“Depression is thought to be the leading cause of disability around the world. At the individual level, there is a close relationship between depression and suicide. In the U.S., there are over 40,000 people a year who die of suicide, and up to 17 percent of people are affected with depression at any given time. So, it’s not only very common but it can have very serious consequences, which is a dangerous combination,” Sanacora said.