Polyethylene Glycol 3350 in the Treatment of Chronic Idiopathic Constipation: Post hoc Analysis Using FDA Endpoints.

"Conflicts of Interest The authors declare the following relevant interests: SM is a consultant of Takeda Pharmaceuticals. AJL is a consultant of Takeda, Allakos, Arena, Gemelli, Ironwood, RedHill, Bayer, Alkermes, QOL Medical, Vibrant, Mylan, Progenity, and BioAmerica; Stock ownership is of Johnson & Johnson, Bristol Myers Squibb, Rock West, and Allurion. WDC is a consultant of AbbVie, Alfasigma, Allakos, Alnylam, Arena, Biomerica, Ferring, Gemelli, Ironwood, Nestlé, Phathom, Progenity, RedHill, Ritter, Salix/Valeant, QOL Medical, Takeda, Urovant, and Vibrant; Grants include Commonwealth Diagnostics International, Biomerica, Salix, QOL Medical, and Vibrant; Stock options are GI OnDEMAND, ModifyHealth, and Ritter."

"The original study was funded by Braintree Laboratories; funding for the reanalysis and for manuscript writing support was provided by Bayer U.S. LLC. Medical writing support was provided by BioCentric, Inc. (Bret Fulton, BSPharm, RPh; Kevin Jarvis, PharmD; Kajal Patel, PharmD) and included preparing a manuscript outline based on author input, preparing a first draft, collating and addressing author comments on drafts, preparing a submission draft, and assisting with revisions based on peer review comments."

" Using the current US Food and Drug Administration-recommended responder definition and other secondary outcomes, once-daily polyethylene glycol 3350 demonstrated substantial and sustained efficacy and safety over 24 weeks in patients with chronic idiopathic constipation. Trial Registration. The original trial was registered with https://clinicaltrials.gov Trial: NCT00153153 ."