Corium Internation (CORI) Reports Streamlined Bioequivalence Development Path for Transdermal Corplex
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Corium Announces Streamlined Bioequivalence Development Path for Transdermal Corplex™ Memantine
August 24, 2016 8:02 AM EDTMENLO PARK, Calif., Aug. 24, 2016 (GLOBE NEWSWIRE) -- 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 companys Pre-Investigational New Drug Application (PIND) submission for once-weekly transdermal Corplex Memantine.
Following review of Coriums pre-IND submission, which included summary results from a Phase 1 pharmacokinetic (PK) study of the product candidate, the FDA concurred with the companys development plans, including its proposal for pivotal... More