
Profile
General Information
Motegrity (prucalopride) is a serotonin-4 (5-HT4) receptor agonist.
Motegrity is specifically indicated for the treatment of chronic idiopathic constipation (CIC) in adults.
Motegrity is supplied as a tablet for oral administration. The recommended dose is as follows:
Adults: 2 mg once daily
Patients with severe renal impairment (creatinine clearance (CrCL) less than 30 mL/min): 1 mg once daily
Clinical Results
FDA Approval
The FDA approval of Motegrity was based on six double-blind, placebo-controlled, randomized, multicenter clinical studies lasting 12 weeks (studies 1-5) or 24 weeks (study 6) conducted in 2,484 adults. During studies, significantly more patients taking Motegrity achieved the primary endpoint (an average of ≥3 complete spontaneous bowel movements [CSBMs] per week over 12 weeks, considered normalization of BM frequency) than those in the placebo group (19-38% Motegrity ≤2 mg vs. 10-20% placebo) across five of six trials. A rapid response was seen with Motegrity as early as week 1, with improvements maintained throughout 12 weeks of treatment.
Side Effects
Adverse effects associated with the use of Motegrity may include, but are not limited to, the following:
headache
abdominal pain
nausea
diarrhea
abdominal distension
dizziness
vomiting
flatulence
fatigue
Mechanism of Action
Motegrity (prucalopride) is a selective serotonin type 4 (5-HT4) receptor agonist, a gastrointestinal (GI) prokinetic agent that stimulates colonic peristalsis (high-amplitude propagating contractions [HAPCs]), which increases bowel motility.
Additional Information
For additional information regarding Motegrity or chronic idiopathic constipation please visit https://www.shirecontent.com/PI/PDFs/MOTEGRITY_USA_ENG.pdf
Approval Date: 2018-12-01
Company Name: Shire Pharmaceuticals