Corium (NSDQ:CORI) touted data today from a pilot bioequivalence study, comparing its Corplex Donepezil transdermal patch to oral Aricept as delivery method for the most commonly prescribed treatment for Alzheimer’s disease.
Data from the pilot study demonstrated that Corium’s transdermal patch met the criteria for bioequivalence to oral Aricept, as measured by primary pharmacokinetic endpoints previously established by the FDA.
The study was a 6-month trial comparing the steady-state pharmacokinetic profiles of once-daily oral Aricept with two differently-sized Corplex Donepezil patches.
“These data support once-weekly Corplex Donepezil as a bioequivalent alternative to daily Aricept,” chief technology officer & VP of R&D Parminder Singh said in prepared remarks. “Sustained and controlled transdermal delivery of donepezil over a seven-day period has the potential to simplify treatment, improve patient compliance, and reduce the GI side effects common to the oral dosage form. We look forward to bringing this convenient therapeutic option to Alzheimer’s disease patients and their caregivers in the near future.”
Corium reported that it plans to launch its pivotal bioequivalence study later this year and expects to file a new drug application for its transdermal patch in 2018.