Indivior Regulatory News (INDV)

8 Apr 2019 09:18

(Sharecast News) - Indivior has published two pieces of clinical research supporting its treatments for opioid use disorder.One clinical study indicated that patients with moderate to severe opioid-use disorder may benefit from higher maintenance injection of once-monthly treatment Sublocade, while the other showed that therapeutic concentrations of buprenorphine reduce the magnitude of respiratory depression caused by opioid painkiller fentanyl. The first piece of research, a post-hoc analysis investigating patterns of abstinence in both injecting and non-injecting opioid users who participated in an earlier long-term trial, found that a Sublocade maintenance dose regimen of 300 mg remained in treatment longer and had a higher study completion rate than those treated with the 100 mg maintenance dose. Users maintaining a 300 mg dose showed a 58% percentage abstinence in weeks 10-25 versus those maintained on 100 mg who were 43% abstinent, with non-injecting users showing 28% continuous abstinence. Indivior said it is planning additional studies to further characterise the patients for whom a higher maintenance dose of the treatment may be warranted. The second study, of eight opioid-tolerant patients, showed that buprenorphine plasma concentrations of 2 ng/mL and higher that were achieved following intravenous infusion reduced the extent of respiratory depression from fentanyl. Fentanyl is an opioid painkiller that is so potent that is often added to or disguised as heroin, with data from the National Institute on Drug Abuse showing that it was the cause of the sharpest increase in US drug overdose deaths in the most recent year for which data exists. On the depression study, chief scientific officer Christian Heidbreder said the potential protective effect warrants additional investigation. Indivior said the buprenorphine plasma concentrations targeted in this study were consistent with concentrations previously shown to block the drug-liking effects of illicit opioids and to significantly reduce illicit opioid use compared with placebo.