Corium presents additional 'positive' results from Corplex Donepezil study
Corium International announced that Parminder "Bobby" Singh, Ph.D., Corium's Chief Technology Officer and Vice President, Research and Development, presented positive pharmacokinetic and pharmacodynamic clinical results from the company's bioequivalence study of Corplex Donepezil in a poster presentation today at the Alzheimer's Association International Conference 2018 in Chicago, IL. Corium had previously reported "positive" PK bioequivalence data comparing once-weekly Corplex Donepezil and daily oral Aricept at steady state. In the poster results presented today, these bioequivalence results were further supported by equivalent pharmacodynamics of Corplex Donepezil and oral Aricept, characterized by the relationship between plasma donepezil concentrations and red blood cell acetylcholinesterase inhibition, which is an important biomarker of the pharmacodynamic response to donepezil. The results also demonstrated that donepezil exposure over the 7-day wear duration was dose proportional for the two intended product strengths, 5 mg/day and 10 mg/day. Further, the pharmacokinetics were independent of age, indicating no dose adjustment is required for Corplex Donepezil based on age. The bioequivalence study was a six-month, three-period, randomized crossover study comparing the steady-state PKPD profiles of once-daily oral Aricept with Corplex Donepezil.