US-based Corium International has reported positive preliminary results from a pilot bioequivalence (BE) clinical trial of Corplex Donepezil in healthy subjects.
Corplex Donepezil is a once-weekly transdermal patch designed to deliver the prescribed treatment for all stages of Alzheimer’s disease.
The results showed that the product met the bioequivalence criteria that were examined using primary pharmacokinetic (PK) endpoints, when compared to oral Aricept (donepezil hydrochloride).
The six-month, randomised cross-over, three-period BE trial was conducted in 60 healthy male and female subjects.
The study compared the steady-state PK profiles of once-daily oral Aricept with 5mg of once-daily donepezil, followed by four weeks of 10mg once a day.
Corium chief technology officer and research and development vice-president Parminder Singh said: “We are extremely pleased that our Corplex Donepezil patches performed as well as we had projected, and that one of the tested patches actually met the regulatory bioequivalence criteria at the pilot stage.
“Based on these results, we can now move forward knowing that we have a product candidate that can meet the bioequivalence-based registration criteria.
“With this exciting clinical progress, we are finalising the scale up and related activities to support the start of our pivotal study this fall, with the objective of filing our new drug application (NDA) in 2018.”
Following the application of more than 500 patches, Corplex was found be well tolerated, and had favourable adhesion with positive skin safety and gastrointestinal side effect profiles.
The main objective of the trial was to establish parameters such as patch size for successful bioequivalence, while secondary objectives included evaluation of safety and tolerability.