DUBLIN, Dec. 21,
2023 /PRNewswire/ -- 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). 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 multicenter,
double-blind, placebo-controlled randomized, clinical trial
(NCT05178316) evaluated two doses (4mg and 0.3mg) of JZP150. The
trial randomized 282 adults aged 18 to 70 diagnosed with PTSD using
the criteria of the American Psychiatric Association's Diagnostic
and Statistical Manual for Mental Disorders, 5th edition
(DSM-5).1
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
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global
biopharmaceutical company whose purpose is to innovate to transform
the lives of patients and their families. We are dedicated to
developing life-changing medicines for people with serious
diseases—often with limited or no therapeutic options. We have a
diverse portfolio of marketed medicines and novel product
candidates, from early- to late-stage development, in neuroscience
and oncology. Within these therapeutic areas, we are identifying
new options for patients by actively exploring small molecules and
biologics, and through innovative delivery technologies and
cannabinoid science. Jazz is headquartered in Dublin, Ireland and has employees around the
globe, serving patients in nearly 75 countries. Please visit
www.jazzpharmaceuticals.com for more information.
Media Contact:
Kristin
Bhavnani
Head of Global Strategic Brand Engagement
Jazz Pharmaceuticals plc
CorporateAffairsMediaInfo@jazzpharma.com
Ireland +353 1 637 2141
U.S. +1 215 867 4948
Investors:
Andrea N.
Flynn, Ph.D.
Vice President, Head, Investor Relations
Jazz Pharmaceuticals plc
InvestorInfo@jazzpharma.com
Ireland +353 1 634 3211
U.S. +1 650 496 2717
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.
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SOURCE Jazz Pharmaceuticals plc