Adamas announces FDA filing acceptance of sNDA to modify the indication statement for GOCOVRI® to include treatment for Parkinson’s disease patients receiving levodopa and experiencing OFF...
Adamas Pharmaceuticals, Inc. (ADMS)
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Source: GlobeNewswire
EMERYVILLE, Calif., June 04, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced that its supplemental New Drug Application (sNDA) for GOCOVRI as a treatment for OFF episodes in Parkinson’s disease (PD) patients receiving levodopa-based therapy has been accepted for review by the U.S. Food and Drug Administration (FDA). The anticipated Prescription Drug User Fee Act (PDUFA) action date is February 1, 2021. GOCOVRI (amantadine) extended release capsules is approved to treat dyskinesia in PD patients treated with levodopa-based therapy, with or without other dopaminergic medications. In the sNDA, Adamas has proposed a revision to the indication statement to include GOCOVRI as an appropriate therapy for the treatment of OFF episodes in PD patients receiving levodopa. The clinical evidence supporting GOCOVRI’s effec
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