{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,8]],"date-time":"2026-04-08T08:31:09Z","timestamp":1775637069118,"version":"3.50.1"},"reference-count":0,"publisher":"Weston Medical Publishing","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J of Opioid Management"],"abstract":"<jats:p>Objective: To characterize the long-term safety and effectiveness of Hysingla\u2122 ER, single-entity, once-daily, extended-release hydrocodone bitartrate tablets formulated with abuse-deterrent properties (HYD), offering a new treatment option for appropriate patients with chronic pain.Design: An open-label study with a dose-titration period (up to 45 days) and a maintenance period (12 months).Patients, participants: A total of 922 patients with chronic nonmalignant and non-neuropathic moderate to severe pain received open-label HYD tablets 20-120 mg; 728 of these achieved a stabilized dose of HYD at the end of dose-titration and entered the maintenance period.Results: The safety profile was similar to that of other oral opioid analgesics, without new or unexpected safety concerns. The most frequent treatment-emergent adverse events (AEs; \u22655 percent) were those commonly associated with the use of systemic \u03bc-opioid analgesics, including nausea, constipation, vomiting, fatigue, dizziness, somnolence, and headache. There were 77 (8 percent) patients with a total of 109 nonfatal treatment-emergent serious AEs. Few patients discontinued due to lack of therapeutic effect overall (6 percent), especially during the 12-month maintenance period (4 percent). Pain relief, sleep, functional health, and activities of daily living all improved at the end of the dose-titration period with HYD. These improvements were maintained through the 12-month maintenance period with stable HYD doses and without increase in concomitant supplemental analgesic medications.Conclusions: This long-term study demonstrated the safety and long-term maintenance of analgesic effect of HYD without continued need for dose increase. <\/jats:p>","DOI":"10.5055\/jom.2015.0283","type":"journal-article","created":{"date-parts":[[2015,8,31]],"date-time":"2015-08-31T14:20:32Z","timestamp":1441030832000},"page":"339-356","source":"Crossref","is-referenced-by-count":13,"title":["12-Month safety and effectiveness of once-daily hydrocodone"],"prefix":"10.5055","volume":"11","author":[{"given":"Warren","family":"Wen, PhD","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Louise","family":"Taber, MD","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shau Yu","family":"Lynch, PhD","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ellie","family":"He, PhD","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Steven","family":"Ripa, MD","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"3008","published-online":{"date-parts":[[2015,7,1]]},"container-title":["Journal of Opioid Management"],"original-title":[],"link":[{"URL":"https:\/\/wmpllc.org\/ojs\/index.php\/jom\/article\/download\/189\/165","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/wmpllc.org\/ojs\/index.php\/jom\/article\/download\/189\/165","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,5,1]],"date-time":"2023-05-01T19:48:24Z","timestamp":1682970504000},"score":1,"resource":{"primary":{"URL":"https:\/\/wmpllc.org\/ojs\/index.php\/jom\/article\/view\/189"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,7,1]]},"references-count":0,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2015,7,1]]}},"URL":"https:\/\/doi.org\/10.5055\/jom.2015.0283","relation":{},"ISSN":["1551-7489","1551-7489"],"issn-type":[{"value":"1551-7489","type":"electronic"},{"value":"1551-7489","type":"print"}],"subject":[],"published":{"date-parts":[[2015,7,1]]}}}