After announcing positive results in phase 3 trials evaluating plecanatide for the treatment of irritable bowel syndrome with constipation (IBS-C), shares in Synergy Pharmaceuticals (NASDAQ: SGYP) rallied 10% this morning.
Plecanatide is already under review by the FDA for approval in treating patients with chronic idiopathic constipation (CIC). That review is being based upon previously reported phase 3 successes that include a relatively low incidence rate of severe diarrhea when compared to other treatment options.
Today, the company rolled out final phase 3 results showing that plecanatide may also address IBS-C, a condition that affects millions of people.
Preliminary overall response rates in the 3 mg and 6 mg plecanatide arms and placebo arm were 30.2%, 29.5%, and 17.8%, respectively, with a p-value of <0.001.
Unsurprisingly, the most common adverse event was diarrhea, which occurred in 5.4% of patients in 3 mg and 4.3% of patients in 6 mg dose groups versus 0.6% of patients in the placebo arm of the study.
A FDA decision on plecanatide in CIC is anticipated on Jan. 29. Management expects to file a supplemental approval application for plecanatide's use in IBS-C in the first quarter.
If approved, plecanatide will face off against Ironwood Pharmaceuticals (NASDAQ:IRWD) and Allergan's (NYSE:AGN) Linzess. Linzess' U.S. net sales increased 34% year over year to $150.5 million in Q2 2016, and U.S. net sales increased 40% year over year to $164 million in Q3 2016.