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FDA accepts new drug application for prucalopride for chronic idiopathic constipation
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Shire announced that the FDA has accepted a new drug application for prucalopride for the treatment of adults with chronic idiopathic constipation, according to a press release.
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,” William D. Chey, MD, professor of gastroenterology and nutrition sciences, director of the GI Nutrition and Behavioral Wellness Program at the University of Michigan Health System, Ann Arbor, and Healio Gastroenterology and Liver Disease Peer Perspective Board member, said in the press release. “Many patients use over-the-counter and prescription medicines, including laxatives, but continue to have constipation symptoms.”
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 (27.8% vs. 13.2%; P < .001). 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 (nausea, diarrhea, and abdominal pain) and headache, and comparable proportions of the treatment and placebo groups experienced adverse cardiovascular events (2% vs. 1.8%). 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,” according to the press release.
“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,” Andreas Busch, PhD, head of research and development at Shire said in the press release. “We look forward to working with the FDA as the agency reviews our application.”
The FDA is expected to rule on the application by Dec. 21, 2018, according to the release.
Disclosures: Busch is employed by Shire. Healio Gastroenterology and Liver Disease was unable to confirm Chey’s relevant financial disclosures at the time of publication.