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Motegrity FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 30, 2018.

FDA Approved: Yes (First approved December 14, 2018)
Brand name: Motegrity
Generic name: prucalopride
Dosage form: Tablets
Company: Shire plc
Treatment for: Chronic Idiopathic Constipation

Motegrity (prucalopride) is a selective serotonin type 4 (5‑HT4) receptor agonist for the treatment of chronic idiopathic constipation (CIC) in adults.

Warnings and Precautions
Suicidal Ideation and Behavior: Suicidal ideation and behavior have been reported in patients treated with Motegrity. Patients are advised to be aware of any unusual changes in mood or behavior, persistent worsening of symptoms of depression, or the emergence of suicidal thoughts or behavior. If any of these symptoms occur, patients should discontinue Motegrity immediately and contact their healthcare provider.

Motegrity is an oral tablet taken once daily, with or without food.
Tablets should be stored at room temperature, in the original container to protect from moisture.

Patients should not Motegrity if they:

  • are allergic to prucalopride or any of the other ingredients
  • have an intestinal perforation or intestinal obstruction due to a structural or functional disorder of the gut wall, obstructive ileus, or severe inflammatory conditions of the intestinal tract such as Crohn’s disease, ulcerative colitis, and toxic megacolon/megarectum.

Adverse Reactions
The most common adverse reactions (≥2%) are headache, abdominal pain, nausea, diarrhea, abdominal distension, dizziness, vomiting, flatulence, and fatigue.

Development timeline for Motegrity

Dec 17, 2018Approval FDA Approves Motegrity (prucalopride) for Adults with Chronic Idiopathic Constipation (CIC)
Oct 18, 2018FDA Advisory Committee Recommends Approval of Shire’s Prucalopride (SHP555) for Chronic Idiopathic Constipation
Jun  3, 2018New Data on the Cardiovascular Safety of Prucalopride Presented at 2018 Digestive Disease Week Annual Meeting
Mar  5, 2018U.S. FDA Accepts New Drug Application for Prucalopride (SHP555) for Chronic Idiopathic Constipation

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.