Document is current

Article History

First Online: 21 February 2020

Compliance with Ethical Standards

:

: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committees (see the electronic supplementary material, Online Resource 1) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the studies.

: These studies were sponsored by Shionogi Inc., Florham Park, NJ. BDSI owns full rights to commercialize Symproic^® (naldemedine) tablets 0.2 mg in the US for opioid-induced constipation. Editorial and writing support was funded by Shionogi Inc.

: James Wild received a stipend from Shionogi Inc. for review of the clinical study report. Lynn R. Webster has received honoraria for consultation from Daiichi Sankyo, Insys, Mallinckrodt, Merck, Pain Therapeutics, Pfizer, Shionogi, Teva, Trevena, and Vallon; honoraria for work on advisory boards from BDSI, Ensysce Biosciences, Mallinckrodt, Neurana Pharmaceuticals, Pfizer, and Trevena; and travel expenses from BDSI, Daiichi Sankyo, Ensysce, Elysium, Insys, Mallinckrodt, Pain Therapeutics, Pfizer, Shionogi, Teva, and Trevena. Martin Hale was a consultant to Shionogi Inc. and received a stipend for review of the clinical study report. Tadaaki Yamada is an employee of Shionogi Inc. who may or may not own stock options.

: All data generated or analyzed during this study are included in this published article and its supplementary information files.