Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced top-line results from the Phase 2 trial (NCT05178316) evaluating JZP150, an investigational small molecule selective fatty acid amide hydrolase (FAAH) inhibitor, on efficacy and safety in adults with post-traumatic stress disorder (PTSD).
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| [21-December-2023] |
| DUBLIN, Dec. 21, 2023 /PRNewswire/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) today announced top-line results from the Phase 2 trial (NCT05178316) evaluating JZP150, an investigational small molecule selective fatty acid amide hydrolase (FAAH) inhibitor, on efficacy and safety in adults with post-traumatic stress disorder (PTSD). The trial did not meet the primary endpoint. There was not a statistically significant decrease in total PTSD symptom severity as measured by the Clinician Administered PTSD Scale (CAPS-5) between JZP150 (4mg or 0.3mg) compared to placebo from baseline to week 12. The trial also did not meet the key secondary endpoints of mean change from baseline to week 12 on the Clinical Global Impression of Severity (CGI-S) and the Patient Global Impression of Severity (PGI-S) scales. “We are deeply grateful to all those who supported and made this trial possible, including the patients who were enrolled, their families, our investigators and trial staff,” said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. “We plan to fully evaluate these data; however, based on top-line results we do not anticipate moving forward with additional JZP150 development in PTSD. We recognize the significant unmet need for PTSD patients and plan to share the findings from this trial with the medical community at a future date.” No new safety signals for JZP150 were observed. The most common treatment emergent adverse events (TEAEs) were headache, nausea and urinary tract infection. These were predominately mild to moderate in severity, and also occurred in placebo-treated participants. About the JZP150 Phase 2 Trial The primary endpoint of the trial measured participants’ changes from baseline to week 12 using the total score from CAPS-5, a structured clinical interview that 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.2 The trial had several secondary endpoints, including changes in scores on the CGI-S and PGI-S scales from baseline to the end of treatment. About Jazz Pharmaceuticals plc Media Contact: Investors: References: 1 American Psychiatric Association (APA). Diagnostic and Statistical Manual for Mental Disorders. 5th ed. Arlington, VA: American Psychiatric Publishing; 2013. 2 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.
SOURCE Jazz Pharmaceuticals plc | ||
Company Codes: NASDAQ-NMS:JAZZ |
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