Bioequivalence of ZUNVEYL a Galantamine Prodrug to Galantamine Hydrobromide Immediate‐Release Demonstrated Under Fed and Fasting Conditions

ZUNVEYL was well-tolerated with no serious adverse events noted. Bioequivalence assessment demonstrated that ZUNVEYL was bioequivalent to galantamine hydrobromide IR for AUC0-t and AUC0-∞, under fed and fasting conditions, and for Cmax under fed conditions. These results combined with those of a steady state study [abstract # 107147], established a scientific bridge to the LDs and the approval of ZUNVEYL, relying on FDA's previous finding of safety and efficacy of the LDs.