FDA Panel Votes on Prucalopride for Chronic Idiopathic Constipation
The Committee reviewed data from an observational pharmacoepidemiology safety study which estimated the risk of MACE.
The Food and Drug Administration (FDA)'s Gastrointestinal Drugs Advisory Committee voted in favor (10 to 0) of approving prucalopride for the treatment of chronic idiopathic constipation (CIC) in adults.
Prucalopride, a selective 5-hydroxytryptamine (serotonin) type 4 receptor (5-HT4) agonist, is a gastrointestinal (GI) prokinetic agent that stimulates colonic peristalsis, increasing bowel motility. It has been studied in over 90 clinical trials over the past 20 years and is currently approved in 82 countries. If approved in the US, it would be the only 5-HT4 receptor agonist indicated for CIC.
The panel's decision was made based on data from from five Phase 3 studies and one Phase 4 trial which evaluated the safety and efficacy of prucalopride in patients with chronic constipation. The Committee also reviewed results from an observational pharmacoepidemiology safety study (N=35,000) which estimated the risk of major adverse cardiovascular events (MACE) in new users of prucalopride vs polyethylene glycol 3350 (PEG). The study was conducted to address safety concerns regarding the potential for cardiovascular risk with 5-HT4 agonists being developed for GI motility disorders. In this mostly female patient population (>90%), the pooled adjusted incidence rate ratio for MACE was 0.64 (95% CI, 0.36, 1.14).
A Prescription Drug User Fee Act (PDUFA) date for prucalopride has been set for December 21, 2018. The FDA is not bound by the Committee's recommendation but takes it into consideration when making its decision.
For more information visit FDA.gov.