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Corium receives positive FDA feedback
June 2016
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MENLO PARK, Calif.—Biopharmaceutical company Corium International Inc. lately announced favorable written feedback from the U.S. Food and Drug Administration (FDA) on its Pre-Investigational New Drug Application submission for once-weekly transdermal Corplex Donepezil. The FDA has informed Corium that if bioequivalence can be adequately shown between Corplex Donepezil Transdermal Delivery System and oral Aricept, further clinical efficacy studies are not necessary. The company also shared positive results from a Phase 1 pharmacokinetics (PK) study assessing optimized proprietary formulations of the product candidate, in which two formulations achieved comparable dosing to oral Aricept with PK profiles that show potential for bioequivalence. Donepezil, the active ingredient in Aricept, is the most broadly prescribed cholinesterase inhibitor, and is approved for treating mild, moderate and severe Alzheimer’s disease. At present, it is only available in a tablet or orally disintegrating tablet form for once-daily administration.

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