Long-acting cocaine esterase (LACE): Assessing the treatment approach

Abstract

Aims: No medications have been approved for the treatment of cocaine dependence. The aim of this work was to determine the need for and commercial viability of a high turn-over cocaine esterase with high specificity and selectivity with activity for 2–4 weeks after subcutaneous injection for treatment of cocaine dependence. Methods: The Technology Transfer Office, University of Michigan requested an independent assessment of the commercial viability of this treatment approach based in part on Collins GT et al., Neuropsychopharmacology. 2012; 37:1092–1103. Thirteen internationally recognized clinical, policy and research leaders in the addiction field participated in a structured phone interview. Six were former CPDD Awardees. Results: Direct quotes – Need: “no benefit from medications; little benefit from outpatient treatment; some benefit from inpatient treatment; but nothing works”. LACE would be a “substantial advance” and “preferred treatment” if patients would take for at least 6 months. “It takes 2 years to get your life back”. Advantages: “solves the compliance problem” and “removes the reinforcing effects of cocaine” “so over time other interventions can work”. Target patients: “Any onewhowasmotivated”; approvable indication and label “relapseprevention”. Reimbursement: “would follow as it has for buprenorphine and naltrexone”. “Higher functioning professionals with a lot to lose would pay directly”; “Accountable/Managed Care andHMOs”. “TheAffordable Care Actwill help”. Challenges: “patient acceptance”; “antibody formation”; “polydrug use”; “injection volume”; “need physician involvement”; “few funding sources”; “regulatory requirements”; “cost of medication”. Market size: Probably $200–350M 3 years after approval and launch. Conclusions: LACE is potentially a superior treatment approach to cocaine dependence, commercially viable and addresses an unmet public health need. Substantial development challenges exist. Government support, an expedited efficacy development plan focused on safety combined with post-marketing studies might be considered. Financial support: Technology Transfer Office, University of Michigan.