Long-Term Safety and Efficacy of @entity17628 in Opioid-induced XXXX in @entity1 with Chronic Noncancer Pain.

@entity1 @entity390 @entity17628 @entity46347 @entity294 @entity4784 @entity391 @entity158 @entity2865 @entity10 @entity1142
BACKGROUND: Chronic opioid analgesic use often causes @entity4784 ( @entity4784 ). This open-label extension study evaluated the safety and efficacy of @entity17628 , a @entity2865 channel ( @entity46347 ) activator, for treatment of @entity4784 in @entity1 with chronic @entity158 . METHODS: Adults with @entity4784 were enrolled from two 12-week, placebo-controlled, double-blind studies and received @entity17628 24   g twice daily for up to 9  months. @entity4784 was defined as <  3 spontaneous bowel movements (SBMs)/week during the 2-week baseline period, of which >=   25% were characterized by hard to very hard stool consistency, subjectively incomplete evacuation, and/or moderate or worse straining. Inclusion criteria required consistent treatment with full opioid agonists >=   30  days prior to screening and throughout the study. RESULTS: All 439 @entity1 who received @entity17628 were analyzed for safety and efficacy. Overall, 24.6% of @entity1 reported treatment-related adverse events (AEs), most commonly @entity390 (5.0%), @entity294 (4.6%), @entity10 (1.6%), and @entity391 (1.4%). No treatment-related serious AEs were reported. @entity390 and @entity294 each led to study discontinuation in 5 @entity1 (1.1%); 2 cases each of @entity390 and @entity294 were rated as severe. Rescue medication usage decreased from month 1 (33.0%) to month 9 (18.6%). Mean weekly SBM frequency (1.4) was significantly increased from baseline at all months (P  <  0.001, range 4.9 to 5.3). Straining, abdominal bloating, abdominal discomfort, stool consistency, @entity1142 severity, and bowel habit regularity were significantly improved from baseline at all months (P  <  0.001). CONCLUSIONS: @entity17628 treatment was well tolerated and improved symptoms and signs of @entity4784 in this 9-month, open-label study of @entity1 with chronic @entity158 .
