Jazz Pharmaceuticals has reported top-line data from the Phase II clinical trial of investigational small molecule selective fatty acid amide hydrolase (FAAH) inhibitor, JZP150, to treat PTSD in adults.

The randomised, double-blind, multicentre, placebo-controlled trial analysed 4mg and 0.3mg doses of JZP150 versus placebo in study subjects. 

In the trial, 282 adult PTSD patients aged 18–70 years were randomised based on the American Psychiatric Association’s Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5). 

The variation in the total score as measured by the Clinician Administered PTSD Scale (CAPS-5) from baseline to week 12 was the trial’s primary endpoint. 

CAPS-5 is a regulated clinical interview deemed the gold standard to diagnose and evaluate PTSD patients. It consists of 30 items that doctors use to diagnose PTSD, assess the symptom severity and determine how the disorder affects the social and occupational functioning of the patient.

Secondary endpoints of the trial comprised variation in scores as evaluated by the Clinical Global Impression of Severity (CGI-S) and the Patient Global Impression of Severity (PGI-S) scales to week 12 from baseline.  

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According to the findings, the trial failed to meet the primary and key secondary endpoints. 

No statistically significant decline in total PTSD symptom severity between JZP150 and placebo was reported. 

In the trial, no new safety signals linked to JZP150 were reported. 

Headache, nausea and urinary tract infection were seen to be the most frequently reported treatment-emergent adverse events (TEAEs). 

Jazz Pharmaceuticals research and development global head and executive vice-president Rob Iannone said: “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 recognise the significant unmet need for PTSD patients and plan to share the findings from this trial with the medical community at a future date.”

In March last year, the company enrolled the first subject in the Phase II EMERGE-201 trial of Zepzelca (lurbinectedin) monotherapy in patients with solid tumours.