A Pressing Need for Pharmacotherapy Development to Treat Drug Addiction: An Editorial from a Legal Perspective

Int Rev Neurobiol. 2016;126:15-38. doi: 10.1016/bs.irn.2016.02.003. Epub 2016 Mar 14.


Only three FDA-approved pharmacological treatments exist for treating opiate dependence, all of which are underprescribed and underused. No FDA-approved pharmacological treatments exist for cocaine or methamphetamine dependence. More evidence-based, FDA-approved treatments are needed for treating drug dependence, but pharmaceutical companies are unlikely to pursue such research without government incentives. Today pharmaceutical companies primarily conduct research and development (R&D) related to "blockbuster" and rare diseases; drug dependence does not fall into either category. Further compounding the problem, pharmaceutical companies have been recently slashing risky areas of research, rather than adopting new areas. Fortunately, the government has a number of options to incentivize pharmaceutical R&D relating to drug dependence treatment, including the following: market exclusivity for new medications, tax breaks, priority review vouchers, liability reduction, and an advanced market commitment.

Keywords: Addiction; Drug dependence; Medication-assisted treatment; Pharmaceutical incentives; Research and development.

MeSH terms

  • Animals
  • Drug Discovery* / legislation & jurisprudence
  • Drug Discovery* / trends
  • Drug Industry / trends*
  • Humans
  • Motivation*
  • Substance-Related Disorders / drug therapy*