Safety and tolerability of ALO-02 (oxycodone hydrochloride and sequestered naltrexone hydrochloride) extended-release capsules in older patients: a pooled analysis of two clinical trials
Open Access
- 17 September 2019
- journal article
- research article
- Published by Taylor & Francis Ltd in Current Medical Research and Opinion
- Vol. 36 (1), 91-99
- https://doi.org/10.1080/03007995.2019.1661679
Abstract
Objective: To assess the impact of age on the safety and tolerability of ALO-02, an abuse-deterrent opioid formulation consisting of oxycodone hydrochloride and sequestered naltrexone hydrochloride, in patients with chronic pain. Methods: Data from two clinical studies in patients with chronic low back pain or chronic non-cancer pain were analyzed. Patients aged ≥18 years who required continuous around-the-clock opioid analgesia for an extended period were grouped into ≥65 years and <65 years age groups. Treatment-emergent adverse events (TEAEs), use of concomitant medications, clinical laboratory measurements, and occurrences of opioid withdrawal using reported AEs and Clinical Opiate Withdrawal Scale (COWS) scores assessed safety. Data pooling was employed for the titration and maintenance phases of both studies. Results: 805 and 436 patients received ≥1 dose of ALO-02 in the titration and maintenance phases, respectively; 121 (15.0%) and 83 (14.6%) patients were aged ≥65 years in the titration and maintenance phase, respectively. Average doses of ALO-02 were lower in the older patients in both phases. Incidences of TEAEs were comparable between age groups in both phases and generally lower in the maintenance phase. Concomitant medications were taken more often by patients aged ≥65 years. Incidences of potentially clinically significant laboratory results were low in both phases with no clinically important differences between age groups. There were few reports of opioid withdrawal events as assessed by reported AEs and COWS scores. One patient aged ≥65 years experienced an AE of opioid withdrawal. Conclusions: The safety and tolerability of ALO-02 is similar in those aged ≥65 years and those aged <65 years with chronic pain. ClinicalTrials.gov identifiers: NCT01571362, NCT01428583.Keywords
This publication has 17 references indexed in Scilit:
- Trends in abuse and misuse of prescription opioids among older adultsDrug and Alcohol Dependence, 2015
- The Effectiveness and Risks of Long-Term Opioid Therapy for Chronic Pain: A Systematic Review for a National Institutes of Health Pathways to Prevention WorkshopAnnals of Internal Medicine, 2015
- Management of chronic pain in older adultsBMJ, 2015
- A multicenter, 12-month, open-label, single-arm safety study of oxycodone-hydrochloride/naltrexone-hydrochloride extended-release capsules (ALO-02) in patients with moderate-to-severe chronic noncancer painJournal of Opioid Management, 2014
- Guidance on the management of pain in older peopleAge and Ageing, 2013
- Management of Persistent Pain in Older Adults: The MOBILIZE Boston StudyJournal of the American Geriatrics Society, 2012
- The Baby Boomer Effect: Changing Patterns of Substance Abuse Among Adults Ages 55 and OlderJournal of Aging & Social Policy, 2010
- Opioids for the Treatment of Chronic Non-Cancer Pain in Older PeopleDrugs & Aging, 2009
- Underutilisation of Opioids in Elderly Patients with Chronic PainDrugs & Aging, 2005
- The Clinical Opiate Withdrawal Scale (COWS)Journal of Psychoactive Drugs, 2003