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Synergy Pharmaceuticals Inc.
SGYP today announced positive
top-line results from the second of two pivotal phase 3 clinical trials
evaluating the efficacy and safety of two different plecanatide
treatment doses (3.0 mg and 6.0 mg), taken as a tablet once-a-day, in
1337 adult patients with chronic idiopathic constipation (CIC).
Preliminary analysis of the data indicates that both plecanatide 3.0 mg
and 6.0 mg doses met the study's primary endpoint and demonstrated
statistical significance in the proportion of patients in the
intention-to-treat population who were durable overall responders
compared to placebo during the 12-week treatment period (20.1% in 3.0 mg
and 20.0% in 6.0 mg dose groups compared to 12.8% in placebo; p=0.004
for both
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