Synergy Pharmaceuticals presents long term safety data for plecanatide for the treatment of chronic idiopathic constipation.

Synergy Pharmaceuticals Inc. presented new long-term safety data of plecanatide, its investigational, orally-administered compound currently being evaluated by the FDA for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). These data, which were presented at the American College of Gastroenterology (ACG) annual scientific meeting, showed that plecanatide was associated with low adverse events and low discontinuation rates in patients with CIC who received plecanatide (3 mg or 6 mg) once-daily for up to 72 weeks. Plecanatide is the first investigational therapy designed to replicate the activity of uroguanylin, a naturally occurring human gastrointestinal (GI) peptide, by working locally in the proximal small intestine to stimulate digestive fluid movement and support regular bowel function.

In this long-term study, which evaluated 2,370 patients, the most common adverse events in both dose groups were diarrhea (7.1%) and urinary tract infection (2.2%). The remainder of adverse events occurred in less than 2% of patients treated with plecanatide. Adverse events leading to discontinuation occurred in 5.3% of patients treated with plecanatide, with discontinuation due to diarrhea occurring in 3.1% of patients. In addition, this study asked patients about level of treatment satisfaction and desire to continue treatment. The median score for treatment satisfaction was 4.0 (4=quite satisfied) and for continuation of treatment was 4.0 (4=quite likely).

Synergy also presented plecanatide data from an integrated efficacy and safety analysis which are consistent with findings of two previously presented double-blind, placebo-controlled Phase III trials that evaluated more than 2,600 patients with CIC over a 12-week treatment period. These additional analyses confirmed a significantly greater response rate of durable overall complete spontaneous bowel movements (CSBM) � a primary endpoint defined by the FDA for regulatory approval in CIC�in each of the two plecanatide dose groups (3 mg, 20.5%; 6 mg, 19.8%) when compared to the placebo group (11.5%, p<0.001 for both doses). these significant increases in csbms with both plecanatide dose groups were seen as early as the first week and maintained through the treatment period compared with placebo. results at 12 weeks also found: 1.secondary endpoints (stool consistency, straining and bloating) were significantly improved compared to placebo.2.adverse event rates were similar across plecanatide-treatment groups and placebo (30.6% in 3 mg and 31.1% in 6 mg dose groups compared to 28.7% in placebo), diarrhea was the most common adverse event (4.6% in 3 mg and 5.1% in 6 mg compared to 1.3% in placebo).3.discontinuation rates were low across all treatment groups (3 mg, 4.1%; 6 mg, 4.5%; and placebo, 2.2%).>