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Trial Underway Testing PTSD Drug Therapy

IED explosion

Improvised explosive device disposal team in Afghanistan (Al-Jazeera, Wikimedia Commons)

30 Dec. 2021. A clinical trial is underway testing an experimental drug to treat the underlying causes and symptoms of post-traumatic stress disorder or PTSD. Jazz Pharmaceuticals plc in Dublin, Ireland, developer of the drug code-named JZP150, says the mid-stage trial enrolled its first participant.

PTSD is a chronic debilitating condition traced to fearful or dangerous experiences — such as military combat — that lead to recurring flashbacks, fearful thoughts, or dreams that interfere with everyday routines and relationships. Symptoms can also include avoidance of situations that remind the individual of fearful experiences, difficulty sleeping, angry outbursts, distorted guilt or blame feelings, and negative thoughts about oneself. Current treatments for PTSD, according to National Institute of Mental Health, are mainly psychotherapy or medications, or both.

JZP150 is designed as a small-molecule drug designed to limit the enzyme fatty acid amide hydrolase, or FAAH. This enzyme breaks down anandamide, a fatty acid in the body that reacts with mood-altering substances, such as cannabis, but also contributes to a healthy mental state. Jazz Pharma says JZP150 selectively inhibits FAAH in people with PTSD to reduce fears that contribute to traumatic memories. The company acquired the experimental drug in Oct. 2020 with its acquisition of SpringWorks Therapeutics, the treatment’s previous developer.

“JZP150 targets a novel mechanism in the brain”

The mid-stage or phase 2 trial plans to enroll 270 adults diagnosed with PTSD at 40 sites in the U.S. Participants are randomly assigned to receive two doses of JZP150 or a placebo, and assessed with a standard 30-item rating scale administered by clinicians. As of today (30 Dec.), the study is not yet listed on ClinicalTrials.gov.

“We need better treatments to help those that are traumatized reclaim their lives,” says John Krystal, Yale University medical school professor of psychiatry and neuroscience in a Jazz Pharma statement. “JZP150 targets a novel mechanism in the brain, and this new phase 2 trial in PTSD will help us to learn more about the molecule’s safety and effectiveness as a potential treatment for patients who would benefit from a novel therapy.”

Jazz Pharma says the Food and Drug Administration granted fast track designation to JZP150, which will help expedite review of the drug. “FDA’s fast track designation of JZP150,” says Rob Iannone, Jazz Pharma’s chief medical officer, “is a notable recognition of both the serious, ongoing, unmet medical needs of PTSD patients and the potential benefits of JZP150’s novel mechanism to treat this debilitating disorder.”

Iannone adds, “The disease burden for PTSD can have a devastating impact on patients and their families for this common condition where the prevalence is expected to increase.”

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