Treating Opioid Use Disorder With a Monthly Subcutaneous Buprenorphine Depot Injection: 12-Month Safety, Tolerability, and Efficacy Analysis
| العنوان: | Treating Opioid Use Disorder With a Monthly Subcutaneous Buprenorphine Depot Injection: 12-Month Safety, Tolerability, and Efficacy Analysis |
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| المؤلفون: | Barbara R. Haight, Norma Lynn Fox, Sunita Shinde, Anne Andorn, David R. Hassman, Paul J. Fudala, Susan M Learned, Christian Heidbreder, Vijay R Nadipelli, Daniel Rutrick, Y Zhao |
| المصدر: | Journal of Clinical Psychopharmacology |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Adult, Male, medicine.medical_specialty, Adolescent, Injections, Subcutaneous, Original Contributions, law.invention, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Randomized controlled trial, Double-Blind Method, law, Internal medicine, medicine, Humans, Pharmacology (medical), Young adult, Adverse effect, Aged, business.industry, Incidence (epidemiology), Opioid use disorder, opioid use disorder, Middle Aged, medicine.disease, Opioid-Related Disorders, buprenorphine, 030227 psychiatry, Clinical trial, Analgesics, Opioid, Psychiatry and Mental health, Treatment Outcome, Tolerability, ComputingMethodologies_DOCUMENTANDTEXTPROCESSING, Female, business, 030217 neurology & neurosurgery, long-term safety, Buprenorphine, medicine.drug |
| الوصف: | Supplemental digital content is available in the text. Background BUP-XR (RBP-6000 or SUBLOCADE) is the first Food and Drug Administration–approved subcutaneously administered monthly extended-release buprenorphine medication for the treatment of moderate or severe opioid use disorder. The primary objective of this phase III study was to assess the long-term safety, tolerability, and efficacy of BUP-XR. Methods This open-label multicenter study in adults with moderate or severe opioid use disorder enrolled 257 participants from a previously conducted placebo-controlled, double-blind phase III study (rollover group) and 412 de novo participants not previously treated with BUP-XR. Participants received an initial injection of BUP-XR 300 mg and subsequent monthly 300 mg or 100 mg flexible doses. By study end, participants received up to 12 injections. Results Overall, 66.8% of participants reported more than 1 treatment-emergent adverse event (TEAE). Injection-site TEAEs (13.2% of participants) were mostly mild or moderate in severity. There were no clinically meaningful changes in safety assessments. An integrated analysis of the double-blind and open-label study participants showed that the incidence of TEAEs, including injection-site TEAEs, was lower in the second 6 months of treatment versus the first 6 months. After 12 months of treatment, 61.5% of the rollover participants and 75.8% of the de novo participants were abstinent. Retention rates after 12 months were 50.6% for the participants who initiated BUP-XR in the double-blind study and 50.5% for de novo participants. Conclusions This study demonstrates that the clinical benefits and acceptable safety profile of BUP-XR demonstrated in the 6-month double-blind study are sustained over a 12-month open-label study, with lower incidence of TEAEs in the second 6 months of treatment. |
| تدمد: | 1533-712X |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9e7f24f63585d4b3e1294bd57656ffd4 https://pubmed.ncbi.nlm.nih.gov/32282418 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....9e7f24f63585d4b3e1294bd57656ffd4 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 1533712X |
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