FDA advisory committee votes unanimously in favor of approval of prucalopride for chronic idiopathic constipation
By a 10-0 vote, the FDA Gastrointestinal Drugs Advisory Committee voted to approve prucalopride for chronic idiopathic constipation, according to a press release from Shire, its manufacturer.
“This investigational compound reinforces Shire’s long-standing heritage in gastrointestinal conditions and deep in-house capabilities in the category,” Andreas Busch, PhD, Shire’s head of research and development said in the release.
Prucalopride — a gastrointestinal prokinetic agent that improves bowel motility by stimulating colonic peristalsis — has been studied in more than 90 clinical trials worldwide over the last 20 years, according to Shire.
The company added that an integrated analysis of six main clinical trials showed significantly more patients treated with prucalopride (27.8%) vs. placebo (13.2%) achieved an average of three or more spontaneous, complete bowel movements each week over the 12-week treatment period.
According to Shire, there were 2,484 adult patients in the integrated efficacy analysis and 2,552 adult patients in the integrated safety analysis; all patients included received prucalopride less than or equal to 2 mg daily or placebo.
Additionally, adverse events that occurred in 5% of prucalopride recipients included abdominal pain, diarrhea, headache, and nausea, and the proportion of patients who experienced any adverse CV events were comparable between those who received prucalopride vs. those who received placebo.
The FDA has set prucalopride’s PDUFA date for Dec. 21.