The FDA today approved constipation remedy plecanatide.
Adult patients affected with chronic idiopathic constipation can soon try a new medication to ease their discomfort. Today the US Food and Drug Administration (FDA’s) announced approval of plecanatide (Trulance/Synergy Pharmaceuticals).
The National Institutes of Health (NIH) had recently reported that approximately 42 million people suffer from constipation. However, “No one medication works for all patients suffering from chronic idiopathic constipation gastrointestinal disorders,” Julie Beitz, MD, director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said in a news release.
The oral treatment, taken once daily, specifically works by targeting the upper gastrointestinal tract to “stimulate secretion of intestinal fluid and support regular bowel function."
Researchers established the safety and efficacy of Trulance in two 12-week, placebo-controlled trials including 1,775 adult participants who were randomly administered a placebo or Trulance, once daily. They required to have been diagnosed with constipation at least six months before the beginning of the study and experience less than three defecations (and other symptoms associated with constipation) per week in the last three months.
The study showed that compared to the placebo group, participants given Trulance were likely to experience improvement in the frequency of complete spontaneous bowel movements. The Trulance group also showed significant signs of improvement in stool frequency, consistency, and straining.
Since the safety and efficacy for Trulance was, so far, only tested in adults, experts advise physicians not to prescribe the medication for patients six to 18 years old, and specifically not in kids younger than six. The most commonly reported side effect was diarrhea, so patients who experience severe diarrhea should stop taking the medication and immediately contact their physicians.
The approval has been anticipated, since favorable trials were reported in December. Wall Street is anticipating that the drug will be sold globally and several financial bloggers are predicting that it’s manufacturer Synergy Pharmaceuticals in NY is likely to soon be acquired by a larger company, Shire in Dublin, Ireland.