Introduction: Biologics to Treat Substance Use Disorders: Vaccines, Monoclonal Antibodies, and Enzymes

Abstract

Traditional, small-molecule approaches have only been marginally successful in developing innovative therapies for substance use disorders (SUDs). For example, there are no FDA-approved medications to treat stimulant (e.g., cocaine and methamphetamine) use disorders, and based on an analysis of trials listed on www.clinicaltrials.gov , no approvals are anticipated during the next 5-7 years. Even when multiple pharmacotherapies are available (e.g., anti-smoking medications), effi cacy over the long term is disappointing. Thus, 1-year abstinence rates are less than 20 % for individuals treated with approved products (e.g., nicotine patches and gum, bupropion, and varenicline). There are multiple factors contributing to this dearth of pharmacotherapies, including a high regulatory "bar" for approval (a period of end-of-trial abstinence is currently the only acceptable endpoint measure)