Shionogi preparing naldemedine submissions

Shionogi & Co. Ltd. (Tokyo:4507) is on track to submit regulatory applications this quarter in the U.S. and Japan for naldemedine ( S-297995) to treat opioid-induced constipation (OIC), spokesperson Lisa Ellen told BioCentury. The company presented data Friday at the American Academy of Pain Medicine from COMPOSE I, one of three Phase III studies in which naldemedine met the primary endpoint.

Shionogi said naldemedine increased the frequency of spontaneous bowel movements (SBM) from baseline for at least nine of 12 weeks on treatment in 47.6% of patients vs. 34.6% for placebo, meeting the endpoint. Abdominal pain occurred in 6.3% of patients receiving naldemedine vs. 1.8% for placebo, while 6.6% of naldemedine-treated patients and 2.9% receiving placebo reported diarrhea. Both adverse events were treatment related. ...