- 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.
- 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.