FDA Approves New Drug for Chronic Idiopathic Constipation
The US Food and Drug Administration (FDA) has approved the drug prucalopride (Motegrity), for the treatment of adults with chronic idiopathic constipation (CIC), a condition that affects 35 million US adults, according to the drug’s manufacturer.
Prucalopride treats CIC by enhancing colonic peristalsis to increase bowel motility, offering patients a new treatment option. The drug is expected to launch in the United States in 2019.
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The approval is indicative of results from 6 double-blind, placebo-controlled, randomized, multicenter clinical studies of 2484 participants. Five of the studies lasted 12 weeks, the sixth lasted 24 weeks.
In the trials, participants who received 2 mg prucalopride once daily had a more significantly normal frequency of bowel movements, defined as having an average of 3 or more complete spontaneous bowel movements per week over 12 weeks, compared with participants who received placebo.
Prucalopride also proved to provide a rapid response, which led to sustainable improvements throughout the study period.
The discontinuation rate for treatment-related adverse events was 5%. The most commonly observed adverse reactions were headache, abdominal pain, nausea, diarrhea, abdominal distension, dizziness, vomiting, flatulence, and fatigue.
“As a gastroenterologist, it is important for me to help patients with CIC find a treatment that works well for them,” Dr Brooks Cash, who is the chief of the division of gastroenterology, hepatology, and nutrition at the University of Texas Health Science Center at Houston, said in a manufacturer-issued press release. “It is exciting to be able to now offer my patients a new treatment option that addresses colonic peristalsis.”
—Colleen Murphy
Reference:
FDA approves Shire’s Motegrity™ (prucalopride), the only serotonin-4 receptor agonist for adults with chronic idiopathic constipation (CIC) [press release]. Cambridge, MA: Shire; December 17, 2018. https://www.shire.com/en/newsroom/2018/december/qmmwqk. Accessed December 20, 2018.
