Prescription Drug Abuse
Prescription medications, particularly opioids, are prone to being abused through physical and chemical manipulation for the purpose of increasing drug concentration in the bloodstream in order to accelerate and intensify their effects. IMS Health, or IMS, a healthcare information firm, estimates that total U.S. sales of analgesic narcotics, or opioids, for therapeutic purposes were $8.3 billion for the 12 months ended September 30, 2012. Drug-related deaths, 40% of which involved the use of opioids in 2008 according to the National Center for Health Statistics, became the leading cause of accidental death in the United States in 2009, surpassing deaths caused by automobile accidents, according to a 2011 report by the U.S. Centers for Disease Control and Prevention. A 2011 research report prepared by the Substance Abuse and Mental Health Services Administration of the U.S. Department of Health and Human Services, or SAMHSA, estimated that nearly 35 million Americans have used prescription pain relievers, including opioid-containing drugs, for non-prescription purposes at least once in their lifetime. The total costs of prescription drug abuse were estimated to be up to $72.5 billion annually for public and private healthcare payors in the United States, according to a 2013 report in the American Journal of Managed Care.
In reaction to the increasing costs and other consequences of widespread prescription opioid abuse, the U.S. government and a number of state legislatures have introduced, and in some cases have enacted, legislation and regulations intended to encourage the development and adoption of abuse-deterrent forms of pain medications. In January 2013, the FDA issued draft guidance that for the first time outlined a regulatory pathway for the approval of drugs with abuse-deterrent claims in their product label. Using our proprietary technology platform, we have developed a pipeline of clinical-stage, opioid-based product candidates in tablet form that are specifically designed to deter abuse by physical and chemical tampering while also providing tailored release of the active pharmaceutical ingredient, or API. In addition to our planned clinical trials for Egalet-001 and Egalet-002, we are currently conducting abuse deterrence studies with both product candidates in accordance with the FDA draft guidance, with the goal of obtaining abuse-deterrent claims in our product labels.