Prucalopride, a 5-HT4 serotonin receptor agonist, has won FDA approval for treating adults with chronic idiopathic constipation, said manufacturer Shire.
The first-in-class oral drug is taken once daily. Shire said it expects the drug to be commercially available in the U.S. sometime in 2019.
An FDA advisory committee voted unanimously in October to recommend prucalopride’s approval. It’s been marketed in other countries for almost a decade, but Shire only recently submitted it for U.S. approval.
Data supporting approval included six randomized, placebo-controlled trials involving nearly 2,500 patients, Shire said. About 20%-40% receiving the drug achieved the primary endpoint of at least three spontaneous bowel movements per week, versus 10%-20% in the placebo groups.
Cardiovascular safety had been an issue with other 5-HT4 agonists, but Shire’s trial data indicated no excess in cardiovascular events. However, suicidal ideation and attempts were reported. The drug’s label will indicate that clinicians should monitor patients for persistent worsening of depression or suicidal thoughts and behaviors. Prucalopride is also contraindicated in patients with inflammatory bowel disorders, perforations, or structural disorders of the gut wall.