Indivior PLC announced the publication of a modeling study in Frontiers in Psychiatry that predicts OPVEE (nalmefene) nasal spray (2.7 mg nalmefene, equivalent to 3 mg of naloxone hydrochloride) resulted in larger reductions in the incidence of simulated cardiac arrest following overdose from high doses of potent synthetic opioids, compared to a 4 mg dose of IN naloxone. Model simulations were performed using a validated translational model developed by the Division of Applied Regulatory Science in the US Food and Drug Administration's Center for Drug Evaluation and Research. In the present study, this translational model was further expanded with data from pharmacokinetic and pharmacodynamic studies with OPVEE2,3 and IN naloxone pharmacokinetic data.

Simulations were conducted in 2000 virtual patients. Following an IV dose of 2.97 mg fentanyl that resulted in a 78% incidence of cardiac arrest in chronic opioid users, a single administration of 4 mg IN naloxone reduced this rate to 47% while a single dose of IN OPVEE reduced this rate to 12%. Four simultaneous doses of 4 mg IN nalxone were needed to lower the incidence of cardiac arrest to 17% which was comparable to that observed following a single dose of OPVEE (12%).

Simulations in opioid naive individuals illustrated the same trend, although a higher incidence of cardiac arrest was predicted in this population given the lack of tolerance to the respiratory effects of opioids. The vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease.

Building on its global portfolio of opioid use disorder treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occating disorders of SUD.