Shire announced that the Food and Drug Administration (FDA) has approved Motegrity (prucalopride) tablets for the treatment of adults with chronic idiopathic constipation (CIC). Motegrity, a selective serotonin-4 (5-HT4) receptor agonist, is a once-daily gastrointestinal prokinetic agent that works by enhancing colonic peristalsis to increase bowel motility. 

The FDA approval was supported by data from 6 double-blind, placebo-controlled, randomized, multicenter trials lasting 12 or 24 weeks (N=2484). A significantly greater proportion of patients treated with Motegrity achieved an average of ≥3 complete spontaneous bowel movements (CSBMs) per week over 12 weeks (“responder”; primary endpoint) vs patients who received placebo across 5 of 6 trials. 

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Efficacy responder rates among patients taking Motegrity 1mg or 2mg vs placebo were as follows: Study 1 (33% vs 10%); Study 2 (38% vs 18%); Study 3 (19% vs 10%); Study 4 (29% vs 13%); Study 5 (24% vs 12%), and Study 6 (25% vs 20%). In addition, a response was seen with Motegrity as soon as week 1, with improvements seen throughout 12 weeks of treatment. 

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The Company is required to conduct 5 post-marketing studies to further evaluate the pharmacokinetics, efficacy, and safety of Motegrity in pediatric patients with CIC aged 6 months to <18 years, as well as pregnant and lactating women with CIC. 

Headache, abdominal pain, nausea, diarrhea, abdominal distension, dizziness, vomiting, flatulence and fatigue were the most common adverse reactions associated with Motegrity.

Motegrity will be available as 1mg and 2mg tablets in 30-count bottles . It is anticipated to launch in 2019. 

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