According to the Institute of Medicine, chronic pain affects approximately 100 million people in the U.S. and 20-30% of the population worldwide – more than heart disease, cancer and diabetes combined. As such, chronic pain is a widespread and growing problem for which many patients do not receive adequate treatment. In many cases, pain is undertreated due to concerns about abuse and tampering with currently available treatment options. Although prescription opioids remain the primary treatment for chronic pain, growing public health concerns regarding the abuse and misuse of these analgesics has, at times, resulted in reduced patient access to safe and effective treatments.
Prescription Opioid Abuse is an Epidemic in the U.S.
The U.S. Centers for Disease Control and Prevention described abuse of prescription drugs in the U.S. as a growing and deadly epidemic. Deaths in the U.S. from prescription opioid overdose have grown from approximately 4,000 in 1999 to approximately 19,000 in 2014.
Extended-release formulations are attractive targets for non-medical abuse since they contain relatively large doses of the active drug. Although the drug is intended to be released over a prolonged period, abusers frequently destroy the time-release mechanism by chewing, crushing or dissolving the formulation in commonly available household beverages or solvents.
In response to 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 of abuse-deterrent forms of pain medications. The FDA has stated that addressing prescription drug abuse is a priority, and the development of abuse-deterrent opioids is a key part of that strategy.