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Party drug ketamine closer to approval for depression

From CNN:

The Food and Drug Administration put the experimental drug esketamine (also known as ketamine) on the fast track to official approval for use in treating major depression, Janssen Pharmaceutical announced Tuesday. This designated "breakthrough therapy" would offer psychiatrists a new method for treating patients with suicidal tendencies and would qualify as the first new treatment for major depressive disorder in about half a century.

In some quarters, though, this potentially effective medicine can't escape its reputation as "Special K," a street drug known for producing a high similar to an out-of-body experience -- and sometimes used as a date rape drug.

Ketamine was first synthesized in 1962 by Calvin Stevens at Parke Davis Laboratories, according to Encyclopedia Britannica. It received FDA approval for use in humans in 1970, and shortly after, Army doctors used the drug on American soldiers fighting in Vietnam as an analgesic and sedative. Yet its minor hallucinogenic side effects soon warned doctors off treating people. Today, ketamine's most common use is as a veterinary anesthetic.

A concern with using ketamine to treat depression is that it can reverse tolerance to opioids, Coffman said. Essentially, patients will get a higher dose of pain medicines, she explained, so any psychiatric uses would require "close oversight" by a multidisciplinary team of doctors.
Iosifescu said the short-term effects are known, but the long-term effects remain mysterious.
 
Another concern is the similarity between prescription ketamine and the street drug, a substance of abuse.

These are all reasons why Janssen's formulation will be provided and administered in doctors' offices or clinics, not distributed by pharmacies.
Posted: 8/22/2016 10:21:00 AM

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