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Executive Brief: An Opioid Abuse-Deterrent Roadmap for the Pharmaceutical Industry

Alcami_Durham-0065-4718.jpgSince 1999, deaths from prescription opioids—drugs like oxycodone, hydrocodone, and methadone—have quadrupled, causing more than 165,000 deaths in the U.S. 

In 2011, the White House published “Epidemic: Responding to America's Prescription Drug Abuse Crisis,” which outlined a comprehensive strategy for responding to America’s prescription drug abuse crisis.

Since then, the initiative to reduce abuse of prescription drugs has gained significant momentum impacting compliance issues, medical community education and market opportunities for opioid drug manufacturers. This paper addresses:

  • Overview of the prescription drug crisis
  • Government Action Directed at the Opioid Drug Abuse Epidemic
  • Medical Community Response—Where Do Doctors Stand?
  • FDA Position on Abuse-Deterrent Opioid Drug Products
  • Three Benefits of Abuse-Deterrent Determination for Opioid Manufacturers
  • Factors Contributing to Opioid Abuse-Deterrence
  • Abuse-Deterrence Determination
  • In Vitro Manipulation and Extraction Studies Approaches

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Topics: Resource Center Abuse-Deterrence