Motegrity Approved for Treatment of Chronic Idiopathic Constipation

Drug Expected to Launch in 2019, Offering Hope to 35 Million U.S. Adults

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

Prucalopride, a selective serotonin-4 (5-HT4) receptor agonist, works by enhancing the natural movements of the colon muscle–known as peristalsis–providing a different option to other prescription CIC treatments.

In double-blind, placebo-controlled, randomized, multicenter clinical studies lasting 12 weeks, more patients taking prucalopride achieved the primary endpoint than those in the placebo group (19–38% for prucalopride ≤2 mg vs. 10–20% with placebo) across five of the six trials. Although cardiovascular safety was an issue with other 5-HT4 agonists, prucalopride’s trial data indicated no increase in cardiovascular events. However, suicidal ideation and attempts were reported.

Prucalopride is contraindicated in patients with inflammatory bowel disorders, perforations, or structural disorders of the gut wall.

The most common adverse reactions are headache, abdominal pain, nausea, diarrhea, abdominal distension, dizziness, vomiting, flatulence and fatigue.

Sources: MedpageToday.com, Drugs.com, December 17, 2018.