Synergy Pharmaceuticals Inc.
) completed patient enrollment for its phase II study on SP-333
being developed for the treatment of patients suffering from
opioid-induced constipation (OIC).
The phase dose-ranging II study is evaluating a 4-week regimen of
SP-333 (1.0 mg, 3.0 mg and 6.0 mg) compared to placebo in patients
who have been taking opioid analgesics for chronic, non-cancer pain
for a minimum of three months.
Synergy Pharma enrolled 260 patients suffering from OIC who have
less than 3 spontaneous bowel movements (SBMs) per week and have
experienced constipation-related symptoms. The main objective of
the study is to evaluate the mean change from baseline in the
number of SBMs during the final week of the treatment period.
Top-line results from the study are expected in the final quarter
Synergy Pharma announced earlier in the month that its lead
candidate, plecanatide, is expected to enter into phase III
development in the fourth quarter of 2014 for the treatment of
irritable bowel syndrome with constipation. The announcement was
made after successfully completing an end-of-phase II meeting with
the FDA. The phase III study will consist of two registration
studies (n=1050 each) in patients receiving either placebo or
Synergy Pharma is developing plecanatide for the chronic idiopathic
constipation (CIC) indication as well. Plecanatide is currently in
phase III development in patients suffering from CIC.
We are encouraged by Synergy Pharma's progress with its pipeline.
However, the constipation market includes
Synergy Pharma currently carries a Zacks Rank #1 (Strong Buy).
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