New Japanese Data Bode Well For Shionogi’s OIC Drug

Shionogi has released the first late-stage clinical results from patients in Japan for its novel opioid-induced constipation drug, the positive data setting the stage for a planned approval filing in this market before the end of the fiscal year.

Shionogi & Co. Ltd.'s peripherally acting mu-opioid receptor antagonist naldemedine has met its primary and key secondary endpoints in the Phase III COMPOSE IV study conducted in Japan in patients with opioid-induced constipation (OIC).

Positive top-line results with the once-daily oral product from one of the other trials in the seven-study COMPOSE suite, COMPOSE I, were released earlier this year. These showed a statistically...

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