UNASSIGNED: Abstract Background: @entity1287 / @entity1443 combination analgesics are frequently prescribed for @entity1118 management; however, @entity1443 presents potential hepatotoxicity to @entity1 and thus dose limitations. These opioid medications are also widely abused. Once-daily, single-entity @entity1287 (Hysingla    ER tablets [HYD]) is a novel formulation with abuse-deterrent properties for the management of @entity1118 and represents a suitable option for those @entity1 receiving analgesics containing the same opioid analgesic, @entity1287 . This post-hoc analysis evaluated the efficacy and safety of HYD in @entity1 whose primary pre-study analgesic was @entity1287 / @entity1443 analgesics (23-31% of the study populations). Methods: Data were analyzed from two Phase III trials, a 12-week randomized, placebo-controlled trial (RCT) and an open-label, 52-week trial. In both trials, a dose-titration period with HYD was followed by respective periods of fixed-dose double-blind (randomized controlled trial [RCT]) or open-label, flexible-dose maintenance treatment. @entity158 intensity was assessed using a numerical rating scale (0-10, 0 = no @entity158 ). For the RCT, primary and sensitivity analyses of @entity158 scores used different approaches to handle missing data. Safety data for both studies were summarized. Results: In the RCT, the mean baseline @entity158 score was 7.3. @entity158 relief was greater with HYD than placebo during double-blind treatment. In the open-label, flexible-dose trial, the majority of @entity1 were maintained on their titrated dose. Mean baseline @entity158 score was 6.3, about 57% of @entity1 completed the 1-year maintenance period, and mean @entity158 scores were between 3.6 and 4.1 during the maintenance period. Use of @entity158 medication decreased or was maintained during the maintenance treatment with HYD. Adverse events in both trials were typical of those associated with opioid analgesics. Conclusion: In @entity1 whose primary pretrial analgesic was @entity1287 / @entity1443 combination tablets, single-entity HYD was effective in reducing @entity158 intensity and in maintaining analgesia over time without need for continued dose increase. HYD's safety and tolerability profiles were similar to other opioid analgesics.

Efficacy and safety of once-daily, extended-release XXXX in individuals previously receiving @entity1287 / @entity1443 combination therapy for @entity1118 .

@entity1 :: ('9606', 'Species') :: ['patients'] @entity1287 :: ('MESH:D006853', 'Chemical') :: ['Hydrocodone', 'hydrocodone'] @entity158 :: ('MESH:D010146', 'Disease') :: ['Pain', 'supplemental pain', 'pain'] @entity1443 :: ('MESH:D000082', 'Chemical') :: ['acetaminophen'] @entity1118 :: ('MESH:D059350', 'Disease') :: ['chronic pain']
@entity1287 :: (MESH:D006853,Chemical) :: ['hydrocodone']
