Dive Brief:
- The Food and Drug Administration on Jan. 19 approved Synergy Pharmaceuticals’ Trulance (plecanatide) for treating chronic idiopathic constipation (CIC) in adults. The agency warned against its use in pediatric patients due to the risk of serious dehydration.
- Safety and efficacy of Synergy’s daily oral drug was established in two 12-week, placebo-controlled trials that included 1,775 adult participants, the agency said.
- New York-based Synergy said Trulance, one of the lead product candidates in its pipeline, is expected to hit the competitive U.S. market in first-quarter 2017.
Dive Insight:
Constipation, often treated with over-the-counter laxatives for acute episodes, may require more therapies or even surgical intervention if it becomes chronic. Overall, about 42 million people are affected by constipation, according to the National Institutes of Health.
Synergy, whose stock climbed more than 5% in trading Jan. 19 following the news, could get a significant boost from the FDA’s approval of Trulance, some analysts said. But they also noted that competition is robust in the market.
The crowded market includes Sucampo’s Amitiza (lubiprostone), FDA-approved in 2006 for CIC and in 2008 for irritable bowel syndrome with constipation. Linzess (linaclotide), a product of Allergan and Ironwood Pharmaceuticals, got the agency’s go-ahead in 2012 for CIC and for IBS-C. Other chronic-constipation medications include serotonin agonists like cisapride and tegaserod, as well as prucalopride and naloxone for opioid-induced bowel dysfunction.
Despite the market competition, Julie Beitz, director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said in the agency’s announcement of Trulance’s approval, "No one medication works for all patients suffering from chronic gastrointestinal disorders."
Indeed, Synergy Chairman and CEO Gary S. Jacob, said the FDA’s approval of Trulance "provides an additional, much-needed, new treatment option" to help adults manage chronic idiopathic constipation.
Jacob described the CIC market as large but underserved. Specifically, chronic idiopathic constipation, which lacks an identifiable cause, affects roughly 33 million Americans and about 14 percent of the global population, he said.
According to Synergy, Trulance is the first drug designed to replicate the function of uroguanylin, a naturally occurring human gastrointestinal peptide that stimulates secretion of intestinal fluid to promote regular bowel function.
Also on Jan. 19, Synergy reported completing two Phase 3 clinical trials for Trulance in 1,000-plus patients with IBS-C. The company said it plans to file a supplemental new drug application (sNDA) in first-quarter 2017, and anticipates a 10-month FDA review period.
Moreover, Synergy is exploring the use of dolcanatide, its second uroguanylin analog, in the treatment of ulcerative colitis.