In the US, cigarette smoking is the

leading preventable cause of death

1. 2017 NYT/CDC  2. NYT 1/6/2017. 3. NIDA Opioid Crisis webpage.

There is a clear unmet need for better treatments and for greater treatment utilization, with a large opportunity for safe and effective pharmacotherapy to treat substance abuse and addiction

“Substance abuse is a national public health crisis that robs the United States of its most valuable asset - its people”  – 2016 Surgeon General Report

​“FDA intends to provide a framework for the development of novel clinical endpoints that can form the basis of product approvals. For example, one endpoint that’s relevant to the treatment of addiction is the craving that fuels continued drug use.” 

    – 2017, FDA Commissioner Scott Gottlieb, M.D.

Additional References:

In 2016, >50K US deaths due to opioid overdose - more than peak year HIV1

While also in the US​...


17M people with Alcohol Use Disorder (AUD)

  • 88K AUD related deaths per year
  • AUD cost the US $250 billion per year
  • 10% of children live with an adult with AUD


3M people use Cocaine

  • 11K cocaine related deaths in 2016
  • 500K cocaine related ER visits per year
  • 750K babies exposed to cocaine during pregnancy per year