Synergy Pharma's Trulance Gets FDA Approval For Treatment Of Adults With CIC

(RTTNews) - Synergy Pharmaceuticals Inc. (SGYP) said that the U.S. Food and Drug Administration has approved Trulance or plecanatide for the treatment of adults with chronic idiopathic constipation or CIC. Trulance will be available in the U.S. later this quarter.

SGYP closed Thursday's regular trading at $6.41, down $0.12 or 1.84 percent. But, in the after-hours trading the stock gained $0.35 or 5.46 percent.

Trulance is the first drug designed to replicate the function of uroguanylin, a naturally occurring and endogenous human gastrointestinal (GI) peptide that is thought to stimulate fluid secretion which results in a stool consistency associated with more regular bowel function.

CIC is a complex, functional GI disorder defined by symptoms including fewer than three bowel movements a week and hard-to-pass or incomplete bowel movements, for which there is no identifiable cause. CIC affects approximately 33 million Americans and an estimated 14 percent of the global population.

The FDA warned that Trulance should not be used in children less than six years of age due to the risk of serious dehydration. Trulance should be avoided in patients six years of age to 18 years of age. The safety and effectiveness of Trulance have not been established in patients less than 18 years of age. Trulance should not be used in patients with known or suspected mechanical gastrointestinal obstruction.

The most common and serious side effects of Trulance was diarrhea. Patients may experience severe diarrhea. If severe diarrhea occurs, patients should stop taking Trulance and contact their health care provider.

Synergy said it has also completed two Phase 3 clinical trials for TRULANCE in irritable bowel syndrome with constipation (IBS-C) and plans to file a New Drug Application Supplement with Clinical Data (sNDA) later this quarter with an expected 10-month review period from submission.