Benzinga - by Vandana Singh, Benzinga Editor.
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) announced top-line results from the Phase 2 trial of 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 PTSD symptom severity as measured by the Clinician-Administered PTSD Scale between JZP150 (4mg or 0.3mg) compared to placebo from baseline to week 12.
The trial did not meet the key secondary endpoints of mean change from baseline to week 12 on the Clinical Global Impression of Severity and the Patient Global Impression of Severity scales.
"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," said Rob Iannone, EVP, global head of research and development of Jazz Pharmaceuticals.
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.
Price Action: JAZZ shares are down 2.15% at $118.50 premarket on the last check Friday.
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