Buvidal safety and efficacy
The clinical research behind Buvidal
As part of its clinical development programme, the safety and efficacy of Buvidal in the treatment of opioid dependence have been investigated in two phase 3 studies.
These studies were carried out with patients with moderate to severe opioid dependence to reflect the likely treatment population.
Phase 3 double dummy, double blind efficacy study
The efficacy and safety profile of Buvidal in the treatment of opioid dependence were established in a pivotal phase 3, randomised, double-blind, double-dummy, active-controlled, flexible-dose study in patients with moderate to severe opioid dependence. In this study, 428 patients were randomised to one of two treatment groups.
Patients in the Buvidal group (n=213) received weekly injections (16–32 mg) during the first 12 weeks followed by monthly injections (64–160 mg) during the last 12 weeks, plus daily doses of placebo sublingual buprenorphine tablets, during the complete treatment period.
Patients in the sublingual buprenorphine/naloxone group (n=215) received weekly placebo Buvidal injections during the first 12 weeks and monthly placebo Buvidal injections during the last 12 weeks, plus daily sublingual buprenorphine/naloxone tablets during the complete treatment period (8–24 mg during the first 12 weeks and 8–32 mg during the last 12 weeks).
During the 12 weeks with monthly injections, patients in both groups could receive one additional 8 mg weekly Buvidal dose per month, if needed.
Patients attended 12 weekly visits during the first 12 weeks and 6 visits during the last 12 weeks (3 scheduled monthly visits and 3 random urine toxicology visits). At each visit, efficacy and safety outcome measures were assessed.
The study met the primary endpoint of non-inferiority in the mean percentage of urine samples negative for illicit opioids during treatment weeks 1–24 for the Buvidal group compared with the sublingual buprenorphine/naloxone group.
Adapted from: Lofwall et al 2018
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The superiority of Buvidal versus sublingual buprenorphine/naloxone was met (pre-specified test order) for the secondary endpoint of the cumulative distribution function (CDF) for the percentage of opioid-negative urine samples during treatment weeks 4–24 (Table 1).
Adapted from: Lofwall et al 2018
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Of the 428 randomised patients, 69.0% (147/213) of the patients in the Buvidal treatment group and 72.6% (156/215) of the patients in the sublingual buprenorphine/naloxone treatment group completed the 24-week treatment period.
Buvidal has demonstrated efficacy in a population of patients with high complexity¹
reflecting the realities of UK clinical practice²⁻⁵.
The clinical development of Buvidal did not take place in patients selected for stability.
The patients who took part in our pivotal Phase 3 trial were out of treatment at the time of recruitment, just over half had a history of intravenous opioid use, and use of multiple substances was common, including cocaine, benzodiazepines, cannabis, and amphetamines.
Phase 3 open-label, long-term safety study
A long-term, open-label, phase 3 safety study with flexible dosing of weekly and monthly Buvidal for 48 weeks was conducted.
