Motegrity Approved to Treat Chronic Idiopathic Constipation

December 14, 2018 – The U.S. FDA has approved MotegrityTM (prucalopride), manufactured by Shire, to treat chronic idiopathic constipation (CIC) in adult patients. It is the first serotonin-4 receptor agonist to receive approval for a CIC indication.

An estimated 35 million adults in the United States have CIC. Women, the elderly, and individuals at socioeconomic disadvantages are most likely to have the condition, which is characterized by symptoms of chronic constipation with no identifiable cause. CIC can lead to abdominal pain, bloating, and difficulty passing stool.

In clinical studies, patients responded to Motegrity as early as the first week of treatment, with improvements maintained for as long as twelve weeks. Motegrity works by helping to stimulate bowel movement. Recommended dosing is 2mg taken once daily.

Suicides, suicide attempts, and suicidal ideation were reported during clinical trials of Motegrity. No direct relationship has been established between the drug and these events; however, healthcare providers should monitor patients’ psychological health during treatment. Patients should discontinue Motegrity immediately and contact their healthcare provider if they experience persistently worsening depression, or emerging suicidal thoughts or behavior.

Shire has not yet announced launch or pricing plans.