Radiopharmaceutical developer Navidea Biopharmaceuticals and the U.S. Food and Drug Administration (FDA) have agreed on protocols for the firm's NAV5001 investigational SPECT imaging agent.
The agreement covers two special-protocol assessments for phase III trials for NAV5001. The assessments are written agreements regarding the design, end points, and statistical analysis for the two pivotal phase III clinical trials for NAV5001, which is used to visualize dopamine transporters in the brain to aid the differential diagnosis of Parkinsonian syndromes from non-Parkinsonian tremor. The company said it is actively preparing for initiation of the trials later this year.
The trials will be used in support of a potential new drug application (NDA), Navidea said.
