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news.US-based Synergy Pharmaceuticals has completed patient enrollment in its Phase II trial of SP-333, its next-generation uroguanylin analog, in patients with opioid-induced constipation (OIC).
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The Phase II trial is designed to compare a four-week dose-ranging regimen of once-daily oral SP-333 (1mg, 3mg and 6mg) against placebo in patients taking opioid analgesics for chronic, non-cancer pain for at least three months.
The multi-center, randomized, double-blind clinical trial will evaluate about 260 patients with OIC who have less than three spontaneous bowel movements (SBMs) per week and who experience constipation related symptoms.
Primary endpoint of the trial is mean change from baseline in the number of SBMs during Week 4 of the Treatment Period.
The company intends to release top-line data from the Phase II trial in the fourth quarter of 2014.
SP-333 is being developed for the treatment of OIC and mild-to-moderate ulcerative colitis.
It is designed to be a highly potent and stable version of the naturally occurring gastrointestinal (GI) hormone, uroguanylin, and resistant to proteolysis in gastric intestinal fluids.
SP-333 has completed Phase I single and multiple ascending dose studies in healthy volunteers and is currently in a Phase II clinical trial for OIC.
The company is also developing a unique formulation of SP-333 for treating GI inflammation in patients with ulcerative colitis.