Long-Term Safety Data for Novel Chronic Idiopathic Constipation Drug Announced
At the American College of Gastroenterology (ACG) annual scientific meeting, Synergy presented new long-term safety data of plecanatide for the treatment of chronic idiopathic constipation (CIC).
In the long-term study (n=2,370), CIC patients treated with plecanatide 3mg or 6mg daily for up to 72 weeks had low adverse events and low discontinuation rates. The most common adverse events were diarrhea (7.1%) and urinary tract infection (2.2%) for both plecanatide dose groups. Adverse events leading to discontinuation were seen in 5.3% of patients treated with plecanatide, with discontinuation due to diarrhea occurring in 3.1% of patients.
Additional data from an integrated efficacy and safety analysis was also presented. The findings were consistent with those of two previously announced Phase 3 double-blind, placebo-controlled studies that evaluated >2,600 patients with CIC over a 12-week treatment period. Also, the findings confirmed a significantly greater response rate of durable overall complete spontaneous bowel movements (CSBM) in each of the plecanatide 3mg (20.5%) and 6mg (19.8%) dose groups vs. the placebo group (11.5%, P<0.001 for both doses).
Plecanatide, an investigational oral compound, is currently being evaluated for the treatment of CIC and irritable bowel syndrome with constipation (IBS-C). It is designed to replicate the activity of uroguanylin, a naturally occurring human gastrointestinal (GI) peptide. It works locally in the proximal small intestine to stimulate digestive fluid movement and help regular bowel function.
For more information visit SynergyPharma.com.