- Fecal Incontinence
Synergy Pharma's constipation drug succeeds in late-stage study
Last Updated: 2015-06-17
By Reuters Staff
(Reuters) - Synergy Pharmaceuticals Inc said its drug for idiopathic constipation met the main goal in a phase 3 trial, sending its shares up 56% in premarket trade on Wednesday.
Plecanatide, Synergy's lead experimental drug, mimics a hormone that promotes fluid secretion in the gastrointestinal tract, allowing for normal bowel function.
More patients consistently responded to the treatment, which was tested at two dosage strengths, than to a placebo, the company said.
Data showed that the drug was safe and effective, with about 1% of patients in the study experiencing serious adverse events, the most common of which was diarrhea, the company said.
Idiopathic constipation affects about 15% of the U.S. population, according to the National Institutes of Health.
Only two drugs are currently approved to treat the condition, Sucampo Pharmaceuticals Inc and Takeda Pharmaceutical Co Ltd's Amitiza (lubiprostone) and Allergan Plc's Linzess (linaclotide).
Amitiza raked in sales of about $331.6 million in 2014, while Linzess racked up sales of $297 million.
Synergy said it plans to apply for regulatory approval in the fourth quarter.