Search Results for: Abuse Potential Assessment

Implementation of Consistent Language as Outlined in FDA Draft Guidance on Drug Abuse and Dependence Labeling Will Support Drug Development, Labeling and Prescriber Decision-Making

By Jack Henningfield, Karen Gerlach, Judy Ashworth, Marion Coe, Sid Schnoll Once finalized, FDA Draft Guidance “Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products — Content and Format” will help ensure more consistent language across drug products about abuse, misuse, addiction, dependence, and tolerance. Our experts in the development... Read more »... Read More >

Regulatory Case Study: A Strategic Abuse Potential Assessment of Acorda Therapeutics’ INBRIJA™ (levodopa inhalation powder)

By Reggie Fant In December 2018, the Food and Drug Administration (FDA) approved Acorda Therapeutics’ INBRIJA, the first levodopa inhalation powder for the intermittent treatment of OFF episodes in people with Parkinson’s disease treated with carbidopa/levodopa. As Parkinson’s disease progresses, many people with Parkinson’s fluctuate between ON periods, during which symptoms are controlled and OFF... Read more »... Read More >

Assessing Abuse Potential of Cannabinoids: Lessons Learned from Past CNS-Active Drug Development

The confusing and conflicting legal status of cannabis and its active constituents can inhibit product development as companies encounter significant and unique barriers to approval and appropriate scheduling. In a complementary webinar, Jack Henningfield, Ph.D., and Daniel Wang described how the development and regulatory submission of other CNS-active drugs, including the development of the FDA-required abuse potential assessment, provide important precedents and models for cannabinoids.... Read More >

Opana ER: What other questions could have been asked?

PA experts observing the recent marketing withdrawal of Opana ER (oxymorphone hydrochloride) considered other data that could be examined to determine if there is something inherent to the formulation that encourages more dangerous avenues of abuse, and the impact of other external factors on real-world safety. On July 6, Endo Pharmaceuticals announced it would withdraw... Read more »... Read More >