The FDA has approved Motegrity for the treatment of adults with chronic idiopathic constipation, according to a company press release.
Motegrity (prucalopride, Shire), a once-daily, oral selective serotonin-4 (5-HT4) receptor agonist, improves bowel motility by stimulating colonic peristalsis, according to the release.
“As a gastroenterologist, it’s important for me to help patients with CIC find a treatment that works well for them,” Brooks Cash, MD, chief of the Division of Gastroenterology, Hepatology, and Nutrition at the University of Texas Health Science Center at Houston, said in the release. “It’s exciting to be able to now offer my patients a new treatment option that addresses colonic peristalsis.”
Suicides, suicide attempt and suicidal ideation has been reported across various clinical trials, according to the release. However, there has been no evidence of a causal association between treatment and an increased risk for suicidal ideation and behavior, according to the release.
The most common adverse events that have been reported in previous trials include headache, abdominal pain, nausea, diarrhea, abdominal distension, dizziness, vomiting, flatulence and fatigue.
The FDA Gastrointestinal Drugs Advisory Committee in October voted unanimously to approve the treatment.
“The approval of [prucalopride] marks a new day in the treatment of CIC,” Howard Mayer, MD, Senior Vice President and Chief Medical Officer at Shire, said in the release. “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.”
Disclosures: Mayer is employed by Shire. Healio Gastroenterology and Liver Disease was unable to confirm Cash’s relevant financial disclosures by time of publication.