Table 1.
Dosing schedule for BUP-XR in the study
| Dose | Scheduled day | Visit | Window (day) | Dose |
|---|---|---|---|---|
| 1 | 1 | Baseline | - | 300mg (loading) |
| 2 | 28 | Week 4 | 21–42 | 300mg (loading) |
| 3 | 56 | Week 8 | 54–70 | 100mg or 300mg |
| 4 | 84 | Week 12 | 82–98 | 100mg or 300mg |
| 5 | 112 | Week 16 | 110–126 | 100mg or 300mg |
| 6 | 140 | Week 20 | 138–168 | 100mg or 300mg |
| 7> | 168> | Week 24> (every 28 days) | Up to 42 days since previous dose | 100mg or 300mg |
The second 300-mg loading dose of BUP-XR will be given after a minimum of 21 days. The 100-mg maintenance dose can be administered up to 2 days ahead of the schedule (i.e. 26 days since the last injection). Unexpected delays of up to 14 days are not anticipated to have any clinical impact on treatment response, so all subsequent doses can be given up to 14 days after the 28-day scheduled interval (i.e. to 42 days)
BUP-XR, extended-release injectable buprenorphine (RBP6000; Sublocade ®)