The Aquestive Therapeutics product, marketed as Exservan, was previously granted an orphan drug designation in January 2018. Its NDA is supported by a number of studies which sought to confirm its bioequivalence to its reference listed drug.
The senior preclinical and clinical imaging scientist at the National Institute of Neurological Disorders and Stroke gave a presentation on a volumetric segmented echo-planar-imaging (3D-EPI) sequence, which could be used to detect novel biomarkers such as the central vein sign rapidly.
The study also added to a growing base of findings which suggest that patients who have failed preventive medications prior to trial participation have lower placebo responses, which could have implications for clinical trial design.
Data from the EVOLVE-1 and EVOLVE-2 phase 3 clinical trials suggest that galcanezumab (Emgality, Eli Lilly) can maintain ≥50% responder rates equivalent to that of placebo while reducing more monthly migraine days for 5 months after halting treatment.