Synergy Pharmaceuticals Inc.'s plecanatide showed superiority compared to placebo in its second phase 3 clinical trial for adult patients with irritable bowel syndrome with constipation.
The drug's 3 mg and 6 mg doses met the study's primary endpoint and showed statistical significance in the percentage of patients who saw a reduction in abdominal pain and an increase of complete spontaneous bowel movement.
During the 12-week treatment period, 30.2% of patients in the 3 mg dose group and 29.5% of patients in the 6 mg dose group saw the improvements, compared with 17.8% of patients in the placebo group.
Synergy reported the drug's superiority compared to placebo in the first phase 3 clinical trial earlier in December.
Plecanatide is currently under review by the U.S. FDA for the treatment of chronic idiopathic constipation, with a targeted approval date of Jan. 29, 2017. Pending approval in this indication, the company plans to file a new drug application supplement for the drug in the first quarter of 2017 for treating irritable bowel syndrome with constipation.