Warren Wen1, Louise Taber2, Shau Yu Lynch3, Ellie He4, Steven Ripa5. 1. Director, Clinical Research, Purdue Pharma L.P., Stamford, Connecticut. 2. Medical Director, Arizona Research Center, Phoenix, Arizona. 3. Associate Director, Clinical Research, Purdue Pharma L.P., Stamford, Connecticut. 4. Associate Director, Biostatistics, Purdue Pharma L.P., Stamford, Connecticut. 5. Executive Medical Director, Clinical Research, Purdue Pharma L.P., Stamford, Connecticut.
Abstract
OBJECTIVE: To characterize the long-term safety and effectiveness of Hysingla™ 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; ≥ 5 percent) were those commonly associated with the use of systemic µ-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.
OBJECTIVE: To characterize the long-term safety and effectiveness of Hysingla™ 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; ≥ 5 percent) were those commonly associated with the use of systemic µ-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.
Authors: John T Farrar; Warren B Bilker; Philip T Cochetti; Charles E Argoff; Jennifer Haythornthwaite; Nathaniel P Katz; Ian Gilron Journal: Pain Date: 2022-01-01 Impact factor: 6.961