FDA approves prucalopride for chronic idiopathic constipation

  • FDA
  • FDA

  • curated by Miriam Davis, PhD
  • Clinical Essentials
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Takeaway

  • The FDA has approved prucalopride (Motegrity), a once-daily oral treatment for adults with chronic idiopathic constipation (CIC).

Why this matters

  • Prucalopride is a new treatment option for a condition affecting 35 million Americans.

Key points

  • Recommended dose for adults is 2 mg once daily.
  • Prucalopride, a selective serotonin-4 (5-HT4) receptor agonist, carries a warning about suicidal ideation and behavior; clinicians are urged to monitor patients and discontinue treatment if they see persistent worsening of depression and emergence of suicidal thoughts and behavior.
  • Prucalopride was studied in 6 double-blind, placebo-controlled randomized multicenter clinical trials (n=2484), with all but 1 study lasting 12 weeks.
    • In 5/6 studies, the prucalopride group had a higher proportion of responders than the placebo group (range, 19%-38% vs 10%-20%; all P≤.002).
    • Responders were defined as having an average of ≥3 complete spontaneous bowel movements per week.
    • A rapid response to prucalopride was seen as early as week 1 and was sustained through week 12.
  • The most common adverse events (≥2%) are headache, abdominal pain, nausea, abdominal distention, dizziness, vomiting, flatulence, and fatigue.
  • Prucalopride is contraindicated in patients with intestinal perforation or obstruction and patients with Crohn's disease or ulcerative colitis.

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