Long-Term Safety and Efficacy of Morphine Sulfate and Naltrexone Hydrochloride Extended Release Capsules, a Novel Formulation Containing Morphine and Sequestered Naltrexone, in Patients with Chronic, Moderate to Severe Pain

摘要: Abstract Context Morphine sulfate and naltrexone hydrochloride extended release capsules contain extended-release pellets of morphine with a sequestered core (MS-sNT). Taken whole, as intended, is released to provide pain relief; if tampered by crushing, mitigate subjective effects morphine. Objectives This open-label study assessed long-term (12-month) safety MS-sNT in patients chronic, moderate severe pain. Methods Safety assessments included determining adverse events (AEs), laboratory assessments, the Clinical Opiate Withdrawal Scale (COWS). Analgesic efficacy was (diary) worst, least, average, current using an 11-point numeric scale (0=none; 10=worst). Results Of 465 receiving one or more doses, 160 completed study. Most (81.3%) experienced AEs, most commonly constipation (31.8%) nausea (25.2%). Thirty-three (7.1%) reported serious AEs; patient's gastrointestinal inflammation colitis were considered possibly drug-related. discontinuations (30%) occurred first month, often because AEs (23.7%). There no clinically relevant changes results vital signs, significant electrocardiogram deemed During each visit after Week 1, 5% fewer had COWS scores indicating mild withdrawal symptoms (range, 0%–4.8%). Five patients, who did not take drug instructed, consistent withdrawal. yielded statistically improvements from baseline mean for all diary items visits, except 1 least Conclusion In this population, when taken directed up 12 months, typical opioid-related side effects. Mean remained low, lack of withdrawal appropriate transition off at completion.