Benzinga | Dec 30, 2021 07:49AM EST

Jazz Pharmaceuticals Announces First Patient Enrolled In Phase 2 Clinical Trial Evaluating JZP150 For Once-Daily Treatment Of Adults With Post-Traumatic Stress Disorder

Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced 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 (impairment of fear extinction and its consolidation), as well as patients' associated symptoms (anxiety, insomnia and nightmares).

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. According to FDA, this designation is intended to facilitate the development and expedite the review of medicines that treat serious conditions and have the potential to address unmet medical needs.

"FDA's Fast Track designation of JZP150 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," said Rob Iannone, M.D., M.S.C.E., executive vice president, research and development and chief medical officer of Jazz Pharmaceuticals. "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. Jazz is dedicated to developing and commercializing innovative medicines and progressing the clinical development of JZP150 is the start to a meaningful journey to help people living with PTSD."

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.1,2 Currently approved medicines have limited efficacy and no cure is available for the condition.3,4,5 Only two antidepressants have received approval from FDA for the treatment of PTSD symptoms in the past 20 years.6,7,8 No approved therapies target the underlying biology that transforms such traumatic events and experiences into the chronic mental health illness of PTSD.

"PTSD profoundly affects the lives, relationships and careers of people living with the disorder. We need better treatments to help those that are traumatized reclaim their lives," said John H. Krystal, M.D., Robert L. McNeil Jr., professor of translational research and professor of psychiatry, neuroscience, and psychology at Yale University. "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."