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Home » Directories » FDA Approved Drugs » Motegrity (prucalopride)

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Motegrity (prucalopride)

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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

    Approval Date: 2018-12-01
    Company Name: Shire Pharmaceuticals
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