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Corium Announces Streamlined Bioequivalence Development Path for Transdermal Corplex(TM) Donepezil Following Positive Pre-IND Communication from FDA

Reports Positive PK Results from Clinical Study of Optimized Once-weekly Corplex Donepezil for Alzheimer's Disease

MENLO PARK, Calif., May 02, 2016 (GLOBE NEWSWIRE) -- Corium International, Inc. CORI, +9.22% a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, today announced receiving favorable written feedback from the U.S. Food and Drug Administration (FDA) on the company's Pre-Investigational New Drug Application submission for once-weekly transdermal Corplex Donepezil.

Following review of Corium's pre-IND submission, which included summary results from the initial Phase 1 pharmacokinetic (PK) study, the FDA provided clear guidance on the company's development plans and registration pathway. The agency advised Corium that if the company can adequately demonstrate bioequivalence between Corplex Donepezil Transdermal Delivery System (TDS) and oral Aricept [(R)] (donepezil hydrochloride) in its planned PK bioequivalence studies, additional clinical efficacy studies will not be required.

"We are pleased that the FDA has concurred with our clinical development plan, which is intended to demonstrate bioequivalence between transdermal Corplex Donepezil and oral Aricept," said Peter D. Staple, President and Chief Executive Officer of Corium. "Preparations are underway for a pilot bioequivalence study, which we look forward to starting later this year. Our objective is to use the results from this pilot study to finalize the design of a pivotal bioequivalence study that we expect to commence by mid-2017."

If the results from the pivotal study supports bioequivalence, Corium expects to be able to submit a 505(b)(2) New Drug Application (NDA) as early as mid-2018.

Positive PK Results for Optimized Once-weekly Corplex Donepezil

Corium also announced positive findings from a new Phase 1 PK study evaluating optimized proprietary formulations of the once-weekly Corplex Donepezil product candidate. Two formulations achieved comparable dosing to oral Aricept with PK profiles that demonstrate the potential for bioequivalence. The company has selected a lead formulation based on these results.

Parminder "Bobby" Singh, Ph.D., Corium's Chief Technology Officer and Vice President, R&D added, "Our optimized Corplex Donepezil patches achieved the targeted sustained delivery of donepezil and skin tolerability requirements for a once-weekly treatment, while also demonstrating enhanced reproducibility. We look forward to advancing our lead formulation into a...