Blog Header

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 >

Q&A with Rachel Beck, Ph.D.: What Do Analytical Chemistry and Forensic Toxicology Contribute to Drug Development and Formulation Evaluation?

Dr. Rachel Beck is an expert in analytical chemistry and forensic toxicology.  In 2018, Dr. Beck joined PinneyAssociates where she is a key contributor to our abuse-deterrent formulation strategy and evaluation team.  She has been qualified as an expert witness in both criminal and civil courts of law and is a fellow of the American... 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 >