New York-based Synergy Pharmaceuticals released results from the first of two phase III clinical trials evaluating the safety and efficacy of plecanatide, its irritable bowel syndrome treatment.
Here's what you need to know.
1. Plecanatide is a once-a-day, orally-administered compound. In this first study, researchers administered the treatment to 1,135 patients with IBS and constipation during a 12-week, double-blind, placebo-controlled trial. The patients either received a three- or six-milligram dose.
2. The trial had a two week pretreatment period, followed by the 12 week trial and a two week posttreatment follow-up period.
3. The most adverse event associated with the treatment was diarrhea which occurred in 3.2 percent of the three milligram patients and 3.7 percent of the six milligram patients, compared to the 1.3 percent associated with the placebo group.
4. Plecanatide is under review by the FDA as a treatment for chronic idiopathic constipation. Synergy plans to file a new drug application supplement with clinical data in the first quarter of 2017, if approved for treatment.
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