ON-DEMAND WEBINAR: Demonstrate Abuse-Deterrent Properties in Opioid Formulations

Prescription opioid abuse has reached epidemic levels in the United States, with nearly 20,000 deaths in 2014 (the most recent year for which statistics are available) from unintentional overdose of prescription opioids and nearly 36,000 deaths in which prescription opioids were either directly or indirectly implicated. This issue has become a major regulatory focus over the last several years and has resulted in the issuance of FDA guidances requiring abuse-deterrent properties for new opioid drug formulation NDA’s (final guidance April 2015) and generic ANDA’s (draft guidance May 2016). A major component of proving the abuse-deterrent properties for a new formulation is the execution of in vitro manipulation and extraction studies, which companies are increasingly turning to CRO’s to perform.

Topics: Webinars Abuse-Deterrence

Overview and Performance of the Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release (ER) and Long-Acting (LA) Opioid Analgesics

Several agencies within the U.S. Federal government are focused on reducing the prescription drug crisis the country is experiencing. How significant is the crisis?

Topics: Abuse-Deterrence Blogs

Battling the Opioid Abuse Epidemic - Top 10 Important Guidances and Resources

Battling the opioid and overall prescription drug abuse epidemic has been a critical focus for many agencies within the U.S. government and industry. The following are a collection of important documents and resources that are important to this initiative.

Topics: Abuse-Deterrence Blogs

The Effect of Abuse-Deterrent Formulations on Opioid Abuse

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. This action was triggered by an alarming increase in drug overdose deaths in the United States from 1999 to 2010. During this time, overdose deaths from opioid pain relievers quadrupled, and have continued to increase.

Topics: Abuse-Deterrence Blogs