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abuse-deterrent properties for new opioid drug formulation NDA’s (final guidance April 2015) and generic ANDA’s (draft guidance May 2016).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.
This webinar will educate companies and individuals that are developing new opioid therapeutics on how to design and execute manipulation and extraction studies in order to demonstrate abuse-deterrent properties. These studies are complex, customized for each formulation, and require considerable effort to execute properly. This webinar is informative and hopefully assist others in proper execution of manipulation and extraction studies, and increase the probability of their success with these products that save lives and reduce addiction.
Length: 60 minutes