Corium Internation (CORI) Reports Streamlined Bioequivalence Development Path for Transdermal Corplex
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Corium International, Inc. (Nasdaq: CORI), 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 (PIND) submission for once-weekly transdermal Corplex Memantine.
Following review of Corium’s pre-IND submission, which included summary results from a Phase 1 pharmacokinetic (PK) study of the product candidate, the FDA concurred with the company’s development plans, including its proposal for pivotal studies based on the demonstration of bioequivalence, or BE, between the Corplex Memantine Transdermal Delivery System (TDS) and oral Namenda XR® (memantine HCl) extended release capsules.
“We are pleased with the FDA’s positive feedback on our bioequivalence-based clinical development plan,” said Peter D. Staple, President and Chief Executive Officer of Corium. “This guidance parallels the feedback that we received from the FDA for Corplex Donepezil, and was well-supported by our clinical study data. The bioequivalence approach enables the development of these important new treatments with reduced risk, time, and cost, compared to typical transdermal development programs.”
“We look forward to advancing our once-weekly Alzheimer’s products through clinical trials, and pursuing a streamlined regulatory pathway. These new transdermal therapeutics are designed to deliver drugs that collectively address an estimated 90% of the current market, and have the potential to improve the lives of patients and their caregivers.”
Corium recently reported results of studies on its optimized formulation of Corplex Memantine, which demonstrated delivery of the required dose of memantine over seven days in a pig study while also indicating acceptable skin tolerability. In preparation for a pilot BE trial, the company next plans to conduct a human PK study of this optimized formulation in healthy subjects to confirm skin tolerability and sustained delivery over one week.
Bioequivalence clinical studies are designed to assess the biological equivalence of pharmaceutical products based on the similarity of their PK profiles to those of already-approved drugs, and are generally performed in healthy subjects. These studies are relatively short in duration of treatment, and provide a development path that is substantially less costly and more streamlined compared to standard clinical development programs.
A Section 505(b)(2) NDA is a new drug application in which the FDA and applicant may rely on certain investigations of safety and effectiveness that were previously conducted by someone other than the applicant, and is applicable to an active drug substance that has previously been approved in a different dosage form.
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