FDA accepts filing of SHP 555 for chronic idiopathic constipation.- Shire.

Shire announced that the FDA has accepted the submission of a New Drug Application (NDA) for SHP 555 (prucalopride). Prucalopride is being evaluated as a potential once-daily treatment option for chronic idiopathic constipation (CIC) in adults. The FDA is expected to provide a decision on or around December 21, 2018, the designated Prescription Drug User Fee Act (PDUFA) action date with FDA noting that timelines are flexible and subject to change based on workload and identification of potential review issues.

An integrated analysis of the six, main randomized, controlled clinical trials evaluated the global efficacy and safety of prucalopride 2 mg daily in men and women with chronic constipation; study designs across the trials were similar. Overall, there were 2,484 adult patients included in the integrated efficacy analysis and 2,552 adult patients included in the integrated safety analysis; all patients included received prucalopride less than or equal to 2 mg/day or placebo. Significantly more patients treated with prucalopride versus placebo (27.8% vs 13.2%; p<0.001) achieved an average of three or more spontaneous complete bowel movements scbms per week over the 12-week treatment period. the most common greater than or equal to 5 treatment-emergent adverse events teaes in the prucalopride group were gastrointestinal disorders nausea diarrhea and abdominal pain and headache. the proportion of patients who experienced any adverse cardiovascular cv events were comparable between groups 1.8 for placebo vs. 2.0 for prucalopride. serious teaes were reported in 1.6 of patients who received prucalopride vs 2.4 of patients who received placebo. no fatal teaes occurred.>

Comment: Prucalopride currently is approved and available in the European Union (EU) where it is marketed by Shire as Resolor, indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.