FDA OKs Chronic Idiopathic Constipation Treatment

Officials with the FDA have approved prucalopride (Motegrity, Shire) for the treatment of chronic idiopathic constipation (CIC), according to a press release.

According to Shire, an estimated 35 million adults are living with CIC, affecting roughly 14% of the adult population. Prucalopride, a selective serotonin-4 (5-HT4) receptor agonist, provides an oral treatment option for adults with the disease. Unlike other medications for CIC, prucalopride works by enhancing colonic peristalsis to increase bowel motility.

The approval is based on 6 clinical studies lasting 12 weeks or 24 weeks evaluating the efficacy of once-daily treatment with prucalopride in 2484 patients. In the studies, significantly more patients receiving prucalopride achieved the primary endpoint, an average of ≥3 complete spontaneous bowel movements per week over 12 weeks, than those who received a placebo. The studies also showed a rapid response with prucalopride treatment in as early as week 1, with improvements maintained throughout 12 weeks of treatment.

Additionally, the FDA has requested 5 post-marketing studies evaluating the pharmacokinetics, efficacy, and safety of prucalopride in pediatric patients with CIC and in pregnant and lactating women with CIC, according to the release.

The most common adverse effects reported in the trial include headache, abdominal pain, nausea, diarrhea, abdominal distension, dizziness, vomiting, flatulence, and fatigue.

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