Jazz Pharmaceuticals' PTSD drug fails in mid-stage trial
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[December 22, 2023]
(Reuters) -Jazz Pharmaceuticals said on Thursday its
post-traumatic stress disorder (PTSD) drug failed to meet the main goal
in a mid-stage study.
Shares of the company fell as much as 4% in after-market trading.
The drugmaker said it does not anticipate moving forward with additional
development of the drug called JZP150.
PTSD is a mental health condition triggered by a terrifying event. While
PTSD is commonly associated with combat, civilians are not immune to it.
Natural disasters, abuse or other trauma may trigger the condition.
The investigational drug failed to show statistically significant
reduction in the severity of PTSD symptoms, as measured on a scale, when
compared with a placebo at 12 weeks.
The scale, known as the Clinician Administered PTSD Scale, is considered
the gold standard for diagnosing and assessing patients with PTSD.
It is a 30-item structured interview with which doctors can assess
symptoms and evaluate their severity as well as the impact on social and
occupational functioning.
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The trial also failed to meet the
secondary goals of the study, the company said.
JZP150 was studied in two doses of 4 milligrams and 0.3 milligrams
in 282 adults aged 18 to 70 diagnosed with PTSD.
The company said no new safety signals for JZP150 were observed.
The most common treatment-emergent adverse events were headache,
nausea and urinary tract infection, predominately mild to moderate
in severity, which had also occurred in placebo-treated patients.
(Reporting by Sriparna Roy in Bengaluru; Editing by Krishna Chandra
Eluri)
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