The FDA has granted breakthrough status to speed the development of esketamine, a ketamine-based antidepressant, based on its efficacy against treatment-resistant depression and seeming ability to work faster than standard antidepressants. Photo by oatawa/Shutterstock
WASHINGTON, Aug. 18 (UPI) -- Known to be used as a party drug, ketamine is on the verge of becoming the first new treatment for depression in decades.
The U.S. Food and Drug Administration granted breakthrough status to esketamine, a form of the drug currently in phase 3 clinical trial as an antidepressant for patients with major depressive disorder with or without imminent risk for suicide.
This is the second time the FDA has granted the drug breakthrough status after it was shown in trials to be effective for treatment-resistant depression in 2013, according to a press release from Janssen Research and Development, the pharmaceutical company developing it.
Ketamine is an anesthetic developed in the 1960s, which has been used for that purpose with both animals and humans, but is most often known for its psychedelic properties under the name "Special K."
In recent years, though, it has been embraced for its potential with depression patients. Recent studies have shown its effects may help with overeating and, more significantly, with major depressive disorder patients who are suicidal.
In some cases, it has been shown to act more quickly than many standard antidepressant drugs. The drug is thought to trigger processes in the brain, developing new connections and alleviating depression symptoms, faster than other treatments.
"What's unique about ketamine is, this happens in hours or days, while with other depression medications, this happens in weeks to months," Dr. Dan Iosifescu, an assoicate professor of psychiatry and neuroscience at the Icahn School of Medicine at Mount Sinai, told CNN.
Previous trials of Janssen's esketamine have been promising, including early results from previous phase 2 clinical trials, which have contributed to FDA's move to expedite development of the drug.
"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," said Dr. Husseini Manji, global head of therapeutic neuroscience for Janssen. "We are currently conducting clinical trials to further evaluate the clinical benefit of esketamine and look forward to working closely with the FDA throughout the development and review process to bring this important potential new therapy to patients in critical need."