FDA Approves New Drug for Chronic Idiopathic Constipation
Prucalopride (Motegrity, Shire) is the only serotonin-4 receptor agonist approved for adults with chronic idiopathic constipation.
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.
Although a causal association between treatment with prucalopride and an increased risk of suicidal ideation and behavior have not been established, Shire noted that suicides, suicide attempts, and suicidal ideation have been reported in clinical trials. Health care professionals should monitor all patients treated with prucalopride for persistent worsening of depression or the emergence of suicidal thoughts or behaviors, as well as educate patients, caregivers, and family members to be aware of any unusual changes in mood or behavior. Prucalopride should be discontinued immediately and a health care provider should be contacted if the patient experiences any of these symptoms.
“The approval of Motegrity marks a new day in the treatment of CIC,” Howard Mayer, MD, senior vice president and chief medical officer of Shire, said in a statement. “This significant milestone reinforces our continued commitment to the GI community and advances our goal of addressing the unmet need of patients suffering from rare, specialized, and common GI conditions.”
FDA approves Shire’s Motegrity (prucalopride), the only serotonin-4 receptor agonist for adults with Chronic Idiopathic Constipation (CIC) [news release]. Shire’s website. https://www.shire.com/en/newsroom/2018/december/qmmwqk. Accessed December 18, 2018.