Clinical Research: Phase 1 - Phase 4

Challenges in Medication Development for Addictions

There is a significant unmet need for medications for addictions, chronic, relapsing disorders that lead to biological and behavioral changes that can have harmful medical and psychological consequences.

Addictions are common, debilitating and costly disorders resulting in more than $740 billion a year in increased healthcare costs, crime, and lost productivity. Multiple medications have been studied for the treatment of addictions, but only a few have been shown to be efficacious in well-controlled studies. To date, medications that have been approved by the U.S. Food and Drug Administration (FDA) target opioid, alcohol, and nicotine addiction, while no approved medications are available for cocaine, benzodiazepine, and other addictions. Further, even when an approved medication is available for treatment, only a fraction of patients receive medication-assisted therapies.

In this white paper, we present an overview of the medications that have been developed for addictive disorders, the study endpoints that have been used for market approval, and the challenges companies may face when developing medications for addictive disorders.

Background on addictions

Addiction is defined as a chronic, relapsing brain disease that is characterized by compulsive drug seeking and use, despite harmful medical and psychological consequences.2 The behavioral changes associated with addiction are also accompanied by changes in brain functioning, especially in the brain’s natural inhibition and reward centers. In fact, brain imaging studies from people addicted to drugs show physical changes in areas of the brain that are critical for judgment, decision-making, learning, memory, and behavior control.

To read more, download the complete white paper by submitting the form on this page.