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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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. 

"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."

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.