Jazz Pharma Enrolls First Patient In Phase 2 Trial Of JZP150 For Post-Traumatic Stress Disorder

(RTTNews) - Jazz Pharmaceuticals plc (JAZZ) announced Thursday that the first patient has been enrolled in a Phase 2 clinical trial evaluating the safety and efficacy of JZP150, an investigational first-in-class small molecule for the treatment of adults with post-traumatic stress disorder (PTSD).

JZP150 is a highly selective inhibitor of the enzyme fatty acid amide hydrolase (FAAH), designed to address the underlying cause of PTSD, as well as patients' associated symptoms.

JZP150 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for PTSD based on the serious nature of the disorder.

PTSD is a psychiatric disorder that affects millions of people and patients frequently have uncontrolled symptoms that impact their ability to perform activities of daily living and function socially. Currently approved medicines have limited efficacy and no cure is available for the condition. Only two antidepressants have received approval from FDA for the treatment of PTSD symptoms in the past 20 years.

The multicenter, double-blind, randomized, placebo-controlled Phase 2 clinical trial will evaluate two doses of JZP150, and is being conducted across 40 U.S. study sites. The trial will enroll 270 adults aged 18 to 70 diagnosed with PTSD.

The primary endpoint of the trial measures participants' changes from the study start to the end of treatment using a score from the Clinician-Administered PTSD Scale. The trial has several secondary endpoints, including changes in scores on the Clinical Global Impressions Severity and the Patient Global Impression of severity scales from study start to the end of treatment.