Neuroimaging studies in CNS drugs approved from 1995 to 2004

• Published in: Clinical pharmacology and therapeutics 2005-02, Vol.77 (2), p.P99-P99
• Main Authors: Uppoor, R. S., Yasuda, S. U., Mummaneni, P., Cooper, E., Pien, H., Sorensen, G., Collins, J., Mehta, M. U.
• Format: Article
• Language: English
• ISSN: 0009-9236; 1532-6535
• DOI: 10.1016/j.clpt.2005.01.007

Background/Aims The objective of this project is to evaluate the use of the imaging modalities in development of Neuropharmacological drugs. Neuroimaging (NI) has the potential to link pharmacokinetics (PK) with pharmacodynamics (PD) and could therefore be an important aid in understanding mechanisms of action and adverse effects of drugs, as well as in identifying mechanisms for variability in drug response. Imaging can be an effective tool in optimizing Neuropharmacological drug development. Methods NDAs approved from 1995 to 2004 in the Division of Neuropharmacological Drug Products were evaluated using a survey type approach. Information collected included the stated purpose of imaging study, PK, imaging, and PD results, and whether the study was used to support dosing or the proposed indication. Evaluation included review of the NDA submission, the final label, the FDA reviews and published literature. Results There were 98 NDAs approved in the Neuropharmacology division out of which 77 have thus far been surveyed. Twelve of the 77 submissions included NI studies. Four of these NDAs had receptor occupancy studies and 3 were used to support the proof of concept. The receptor occupancy results are in reasonable agreement with the final selected doses. Conclusions A database capturing characteristics of NI studies in drug development has been initiated. Future efforts will focus on identifying those NI characteristics in the literature and in IND/NDAs that can be used to optimize drug development. Clinical Pharmacology & Therapeutics (2005) 77, P99–P99; doi: 10.1016/j.clpt.2005.01.007