The Food and Drug Administration (FDA) accepted the new drug application (NDA) for SHP555 (prucalopride) as a potential treatment option for chronic idiopathic constipation (CIC) in adults, announced Shire.

If the drug obtains final approval, it will be the only 5-HT4 agonist available in the United States for the treatment of chronic idiopathic constipation (CIC), a condition that affects approximately 35 million Americans, according to the press release.

Chronic idiopathic constipation is a commonly-occurring condition that affects nearly one in eight people in the United States,” said William D. Chey, director of the GI Nutrition and Behavioral Wellness Program at the University of Michigan Health System, Ann Arbor.

“Many patients use over-the-counter and prescription medicines, including laxatives, but continue to have constipation symptoms,” Chey added.

Prucalopride is a gastrointestinal prokinetic agent that stimulates colonic peristalsis, thus improving bowel motility. It is currently approved for chronic constipation in the European Union and other countries outside of Europe, but it remains an investigational compound in the U.S.

The new drug application includes data from five phase 3 and one phase 4 double-blind, placebo-controlled trials, according to the press release.

An integrated efficacy analysis from these trials (n = 2,484) showed that significantly more patients achieved an average of three or more complete spontaneous bowel movements per week over 12 weeks of treatment vs. placebo.

An integrated safety analysis (n = 2,552) showed the most frequent treatment-emergent adverse events, occurring in at least 5% of the treatment group, included GI disorders and headache, and comparable proportions of the treatment and placebo groups experienced adverse cardiovascular events.

Serious treatment-emergent adverse events occurred in 1.6% of the treatment group vs 2.4% of the placebo group, and no treatment-emergent adverse events resulted in death.

Shire also included results from a real-world observational safety study in the NDA to estimate the risk for major adverse cardiovascular events associated with prucalopride vs. polyethylene glycol, as “drugs similar to prucalopride have been associated with adverse cardiovascular events in the past.” 

“Today’s acceptance of the NDA reinforces the breadth and depth of Shire’s capabilities in gastrointestinal conditions and commitment to providing new treatment options for patients living with hard-to-treat conditions,” said Andreas Busch, head of research and development at Shire.