Jazz Pharmaceuticals Announces First Patient Enrolled in Phase 2 Clinical Trial Evaluating JZP150 for Once-Daily Treatment of Adults with Post-Traumatic Stress Disorder
JZP150 was granted Fast Track designation by the
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
About the Phase 2 Trial
The multicenter, double-blind, randomized, placebo-controlled 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 using the criteria of the
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 (CAPS-5). CAPS-5 is structured clinical interview and is considered the gold standard for diagnosing and assessing patients with PTSD. It includes 30 items with which physicians can make PTSD diagnoses and evaluate the severity of the symptoms as well as the impact on social and occupational functioning.11 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.
JZP150 is an investigational small molecule formulated to selectively inhibit the enzyme fatty acid amide hydrolase (FAAH) and is currently in development for the treatment of post-traumatic stress disorder (PTSD) in adults. In PTSD, fear extinction deficits contribute to the persistence of traumatic memories.12 Interventions to promote fear extinction learning are the foundation of PTSD treatment.12 Current first-line pharmacological treatments, such as selective serotonin reuptake inhibitors, mitigate some symptoms of PTSD, but are not designed to address the core underlying problem (fear extinction learning and its consolidation).12 Data from previous preclinical and clinical studies with JZP150 provide evidence that FAAH inhibition can improve the recall of fear extinction memories and attenuate the anxiogenic effects of stress.13,14,15,16,17
Jazz acquired worldwide rights to JZP150, formerly called PF-04457845, from SpringWorks Therapeutics in
About Post-Traumatic Stress Disorder
Post-traumatic stress disorder (PTSD) is a common psychiatric condition that can result from direct or indirect exposure to traumatic events and experiences.3 Individuals with PTSD have intense and disturbing thoughts and feelings related to their experience that persist long after their traumatic event, and they may relive the event through flashbacks or nightmares and feel sadness, fear, anger, and detachment from other people.19 The burden of PTSD is immense with patients struggling to control their symptoms, perform daily activities and function socially.1,2 There is a significant unmet need for patients with PTSD as there is no therapy that treats the root cause of the disorder.
About Jazz Pharmaceuticals plc
Caution Concerning Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the significance of JZP150's Fast Track designation; the potential timing of the availability and potential benefits of JZP150 for people with post-traumatic stress disorder and other statements that are not historical facts. These forward-looking statements are based on
Vice President, Head, Investor Relations
- Kessler RC,
Aguilar-Gaxiola S, Alonso J, et al. Trauma and PTSD in the WHO world mental health surveys. European Journal of Psychotraumatology. 2017;8(sup5):1353383.
- Watson P. PTSD as a public mental health priority. Current Psychiatry Reports. 2019;21(7):1-2.
American Psychiatric Association(APA). Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Arlington, VA: American Psychiatric Publishing; 2013.
- Goldstein RB, Smith SM, Chou SP, et al. The epidemiology of DSM-5 posttraumatic stress disorder in
the United States: results from the National Epidemiologic Surveyon Alcohol and Related Conditions-III. Soc Psychiatry Psychiatr Epidemiol. 2016;51(8):1137-1148. doi:10.1007/s00127-016-1208-5.
- Burri A, Maercker A. Differences in prevalence rates of PTSD in various European countries explained by war exposure, other trauma and cultural value orientation. BMC Res Notes. 2014;7:407. Published 2014 Jun 28. doi:10.1186/1756-0500-7-407.
- Ehret M. Treatment of posttraumatic stress disorder: Focus on pharmacotherapy. Ment Health Clin. 2019;9(6):373-382. Published 2019 Nov 27. doi:10.9740/mhc.2019.11.373
- Zoloft® (sertraline hydrochloride) tablets, for oral use. US Prescribing Information. Roerig,
New York, NY, US. December 2016.
- Paxil® CR (paroxetine) extended-release tablets, for oral use. US Prescribing Information. GlaxoSmithKline,
Research Triangle Park, NC, US. September 2019. American Psychiatric Association(APA). Diagnostic and Statistical Manual for Mental Disorders. 5th ed. Arlington, VA: American Psychiatric Publishing; 2013.
- Weathers FW, Litz BT, Keane TM, Palmieri PA,
Marx BP, Schnurr PP. The PTSD Checklist for DSM-5 (PCL-5). 2013. Scale available from the National Center for PTSDat www.ptsd.va.gov. Accessed December 29, 2021.
- Weathers FW, Blake DD, Schnurr PP, Kaloupek DG, Marx BP, Keane TM. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). [Assessment] 2013. Available from www.ptsd.va.gov.
- Mayo LM, Rabinak CA, Hill MA, et al. Targeting the endocannabinoid system in the treatment of posttraumatic stress disorder: a promising case of preclinical-clinical translation. Biological Psychiatry. 2021
- Kathuria S, Gaetani S, Fegley D, et al. Modulation of anxiety through blockade of anandamide hydrolysis. Nat Med. 2003;9(1):76-81.
- Patel S and Hillard CJ. Pharmacological evaluation of cannabinoid receptor ligands in a mouse model of anxiety: further evidence for an anxiolytic role for endogenous cannabinoid signaling.
Journal of Pharmacology and Experimental Therapeutics. 2006;318(1):304-11.
- Mayo LM, Asratian A, Lindé J, et al. Elevated anandamide, enhanced recall of fear extinction, and attenuated stress responses following inhibition of fatty acid amide hydrolase: a randomized, controlled experimental medicine trial. Biological Psychiatry. 2020;87(6):538-47.
- D'Souza DC,
Cortes-Briones J, Creatura G, et al. Efficacy and safety of a fatty acid amide hydrolase inhibitor (PF-04457845) in the treatment of cannabis withdrawal and dependence in men: a double-blind, placebo-controlled, parallel group, phase 2a single-site randomised controlled trial. The Lancet Psychiatry. 2019;6(1):35-45.
- Mayo LM, Asratian A, Lindé J, et al. Protective effects of elevated anandamide on stress and fear-related behaviors: translational evidence from humans and mice. Mol Psychiatry. 2020;25(5):993-1005. doi:10.1038/s41380-018-0215-1
Jazz Pharmaceuticals. Jazz Pharmaceuticals Acquires SpringWorks Therapeutics' FAAH Inhibitor Program. October 26, 2020. http://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-acquires-springworks-therapeutics-faah American Psychological Association. Post-traumatic Stress Disorder. https://www.apa.org/topics/ptsd. Accessed December 29, 2021.
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