FDA Expected to OK Ketamine-Like Depression Drug

By | March 5, 2019

A safer alternative?

Esketamine, the new drug seeking FDA approval, is meant to be a much safer version of ketamine.

Speaking this week with National Public Radio, Courtney Billington, president of Janssen Neuroscience, said esketamine will be marketed under the brand name Spravato.

Billington said numerous restrictions on Spravato’s use will be put in place.

First, only patients who have failed at least two other antidepressants will be eligible for a prescription, and “Spravato will not be dispensed directly to a patient to take it home. It will only be available in approved and certified treatment centers,” he said.

Also, unlike ketamine, “the amount of active ingredient that’s in this product is at a very, very low dose,” Billington told NPR.

That’s important, because ketamine can trigger disturbing effects such as hallucinations and dissociation, a sense of being disconnected from one’s body and the world. Spravato shouldn’t carry those risks, Billington said.

In the meantime, clinics offering generic ketamine continue to do business.

It’s not even clear exactly how ketamine works to improve mood, Schatzberg said.

One common theory is that it affects the brain’s response to the neurotransmitter glutamate. Neurotransmitters are chemicals that send signals from one part of the brain to another and from the brain to the body. Essentially, the thinking goes, ketamine rewires the brain.

But Schatzberg, a professor of psychiatry and behavioral sciences at Stanford University, was part of a small study published online in The American Journal of Psychiatry. It suggested another explanation — that ketamine somehow activates opioid receptors in the brain.

“We could be exposing people to untoward consequences from a drug that works through an opioid mechanism,” he said. With an opioid addiction crisis in full swing across the United States, “we need to study [ketamine] more,” he added.

When other treatments have failed

Dr. Robert Watson, Godfrey’s doctor at Sierra Ketamine Clinics in Reno, agreed that more study is needed. He thinks researchers could learn much from clinics like his that offer ketamine as an off-label depression treatment.

Watson said he’s seen the drug help many patients whose depression hasn’t responded to other medications and/or talk therapy.

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