A phase 3 trial of Synergy Pharmaceuticals Inc.'s plecanatide showed statistical significance compared to placebo in the percentage of patients who saw a reduction in abdominal pain and an increase of complete spontaneous bowel movement.
Plecanatide's efficacy and safety is currently being evaluated in two phase 3 trials for the treatment of adult patients with irritable bowel syndrome with constipation.
During the 12-week treatment period, 21.5% of patients in the 3 mg dose group and 24.0% in the 6 mg dose group saw the improvements, compared to 14.2% in the placebo group. The most common adverse event was diarrhea, which occurred in 3.2% of patients in 3 mg and 3.7% of patients in 6 mg dose groups compared to 1.3% of placebo-treated patients.
Results from the second phase 3 trial are expected to be announced later in December, Chairman and CEO Gary Jacob said in a statement.
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, Synergy plans to file a new drug application supplement for plecanatide in the first quarter of 2017 for treating irritable bowel syndrome with constipation.