Support Groups

FDA approves expedited development/review of the drug Esketamine

A pharmaceutical company announced Tuesday that the Food and Drug Administration has approved expedited development and review of the drug esketamine, commonly called ketamine, in treating major depression.

Ketamine has been approved as an anesthetic for humans and animals and is one of the most popular painkillers for children in emergency rooms across the country.

It’s also popular as both a party drug and a date-rape drug and became a controlled substance in 1999.

If approved, the drug could provide a breakthrough for people with suicidal thoughts as well as offer one of the first new treatments in 50 years for people with major depression.

What is Ketamine?

Ketamine is a dissociative anesthetic that causes hallucinations, distorting sight and sound to make the user feel disconnected and not in control, according to the Drug Enforcement Administration.

It can cause sedation, inability to move, relief from pain, and amnesia, which is why it has been used to facilitate sexual assault.

Its effects can be similar to LSD or PCP, but hallucinations last 30 to 60 minutes as opposed to several hours. Such “Special K trips” are called “K-holes,” “K-land,” “baby food” and “God,” according to the DEA.

In 2014, 1.5 percent of 12th graders said they had used ketamine in the past year, according to a National Institute on Drug Abuse survey.

Why is it being researched to treat depression?

In 2006, researchers found that just one dose of ketamine caused “robust and rapid antidepressant effects” in patients with major depression within two hours and lasted for a week.

Soon after, many psychiatrists began treating patients “off-label” to much success, according to NPR.

What’s next for ketamine?

Janssen Research & Development, which is a pharmaceutical company under Johnson & Johnson, announced that the FDA granted ketamine “Breakthrough Therapy Designation,” which speeds up development and review of a drug when trials show it may be a “substantial improvement over existing therapies.”

This is the second time ketamine has received such designation; it first earned it for treatment-resistant depression in November 2013.

“In the U.S. alone, there are more than 41,000 suicides each year, many of which result from untreated or poorly treated major depression,” Dr. Husseini Manji, head of neuroscience research and development at Janssen Pharmaceutical Companies, said in a statement.

“This designation reinforces the potential of esketamine as a novel treatment for patients with major depressive disorder who are at imminent risk for suicide, a condition for which there currently is no approved treatment and which represents a major public health challenge,” he said. Read More



(Visited 121 times, 1 visits today)

%d bloggers like this: