FDA Approves Ketamine-based Antidepressant

Ketamine is a drug that kind of flies under the radar. While it has some accepted medical uses (mostly in veterinary medicine), it also has a rep as a party drug. That means it is bad.

Ketamine also is on the United Nations’ World Health Organization Essential Medicines List, “a list of minimum medicine needs for a basic health-care system”. That means it is good.

Now, a ketamine-based drug has been approved for people with depression for whom other antidepressants have proven ineffective. Is that good or bad? That depends on whether you believe it is a highly dangerous and addictive drug.

Ketamine doesn’t have its own page on the National Institute on Drug Abuse web site. That may be because it’s only a Schedule III drug on the Controlled Substances list, and so much less dangerous or addictive – according to the DEA – than such irredeemable drugs as heroin and marijuana, on Schedule I and more acceptable than prescription painkillers oxycodone and hydrocodone, on Schedule II.

Ketamine doesn’t have the rogue’s gallery of famous people who have died due to its overdose. Two of three relatively famous attributed deaths were due to “misadventure” – website founder Gary Frisch falling out a window, and author D.M. Turner drowning in a tub, presumably accidentally – not an overdose. The third, adult film actor Joey Stefano, took a drug cocktail that also included cocaine, heroin, and morphine.

In 2016 the United Nations’ World Health Organization (WHO) wrote that “The risk of fatal intoxication associated with ketamine is very low”, identifying only 12 deaths between 1987 and 2000, and only three where ketamine was the sole drug detected. No details are given, but even those may have been due to “misadventure”, not overdose. (A web search for “ketamine overdose deaths” produced no unequivocal results.)

Lee Hoffer – a medical anthropologist and one of the people who approved esketamine during the FDA review – agreed that ketamine is not “a highly addictive street drug”.

Basically, its effects often aren’t desirable to many people: a feeling of dissociation, out-of-body experiences, time passing slowly. Typically, it has little risk of addiction, no withdrawal pains when not used, and few people want to use it often enough to become dependent. So, not many dealers bother with it.

Ketamine also is on the WHO Essential Medicines List, “a list of minimum medicine needs for a basic health-care system”. That means it is good.

Not to say it can’t be abused, but for such a relatively safe drug, the Food and Drug Administration is making it awfully hard to use or afford. This is despite the fact that the FDA has approved the ketamine-based medicine for the treatment of “treatment-resistant depression”.

Esketamine (brand name Spravato) is a nasal spray intended for patients who have not responded to other antidepressants over a period of years. It works almost instantly, but patients are required to have it administered in a doctor’s office and to remain there for two hours in case they suffer negative side effects such as dissociation. Even when they leave, they must agree not to drive or operate heavy machinery for 24 hours.

Esketamine seems designed for solo, individual use, as opposed to ketamine itself, which has been used for similar antidepressant purposes but delivered intravenously over a 45 minute period. Esketamine is administered twice a week, for four weeks (as opposed to intravenous ketamine: six times over two weeks). , for about $500 per infusion,

Despite that increased ease, it may actually cost patients more. Intravenous ketamine is “$500 per infusion”, for a total of about $3,000. One treatment of esketamine is expected to be between $4,720 and $6,785 or more than $37,000 minimum.

Alcoholism is a problem. Opioid and methamphetamine addiction is a problem. Ketamine and esketamine don’t seem to be. Don’t make it too difficult or expensive for people who need it to get it.

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Medical disclaimer:

Sunshine Behavioral Health strives to help people who are facing substance use disorder, addiction, mental health disorders, or a combination of these conditions. It does this by providing compassionate care and evidence-based content that addresses health, treatment, and recovery.

Licensed medical professionals review material we publish on our site. The material is not a substitute for qualified medical diagnoses, treatment, or advice. It should not be used to replace the suggestions of your personal physician or other health care professionals.

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