The Gastrointestinal Drugs Advisory Committee voted unanimously (10 to 0) that the risk-benefit profile of Prucalopride supports its approval for chronic idiopathic constipation. It also voted unanimously that the potential risk of cardiovascular adverse events with prucalopride treatment has been adequately addressed by the firm. If the FDA follows the advice of its Committee, prucalopride will be the only readily available 5-HT4 receptor agonist in the US for adults with CIC. The advisory committee also voted unanimously (10 to 0) that the potential risk of cardiovascular adverse events with the use of prucalopride in adults with CIC has been adequately addressed by Shire. Prucalopride, a serotonin type 4 (5-HT4) receptor agonist, is a gastrointestinal prokinetic agent that stimulates colonic peristalsis, increasing bowel motility. Drugs similar to prucalopride have been associated with adverse cardiovascular (CV) events in the past.
Comment: Resolor (prucalopride) was approved in 30 European countries (EU 27, Norway, Iceland and Liechtenstein) for the symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief in October 2009. The FDA is expected to provide a decision on or around 21 December 2018, the designated Prescription Drug User Fee Act (PDUFA) action date with FDA noting that timelines are flexible and subject to change based on workload and identification of potential review issues.