Motegrity (prucalopride)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved December 2018

Specific Treatments:

chronic idiopathic constipation

Therapeutic Areas

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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