FDA approves Motegrity for chronic idiopathic constipation.- Shire.

Shire announced that the FDA has approved Motegrity (prucalopride), a once-daily, oral treatment option for adults with Chronic Idiopathic Constipation (CIC). Motegrity is expected to launch in 2019 in the United States, where an estimated 35 million adults are living with CIC. The efficacy of once-daily treatment with Motegrity was evaluated in six double-blind, placebo-controlled, randomized, multicenter clinical studies lasting 12 weeks (studies 1-5) or 24 weeks (study 6). Of the 2,484 patients, most were female (76%) and Caucasian (76%), with an average age of 47 (+/- 16 years).

During studies, significantly more patients taking Motegrity achieved the primary endpoint (an average of at least 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 less than or equal to 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. The FDA has requested that Shire conduct five post-marketing studies evaluating the pharmacokinetics, efficacy, and safety of Motegrity in pediatric patients with CIC (6 months old to less than 18 years of age) and pregnant and lactating women with CIC treated with Motegrity.