ADAMAS PHARMACEUTICALS, INC. (NASDAQ:ADMS) Files An 8-K Other Events
Item 8.01 Other Events.
ADAMAS PHARMACEUTICALS, INC. (NASDAQ:ADMS) Files An 8-K Other Events
On June 4, 2020, Adamas Pharmaceuticals, Inc. (the “Company”) 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, the Company 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 effect on OFF time was demonstrated in two large pivotal Phase 3 trials and is currently included in the GOCOVRI prescribing information.
About ADAMAS PHARMACEUTICALS, INC. (NASDAQ:ADMS)
Adamas Pharmaceuticals, Inc. is a pharmaceutical company. The Company is engaged in developing medicines to manage the daily lives of those affected by chronic neurologic disorders. It offers a platform based on an understanding of time dependent biologic effects of disease activity and drug response to achieve relief without tolerability issues. It has developed a portfolio of chrono-synchronous therapies to address chronic neurologic disorders. Its first product candidate is ADS-5102, a chrono-synchronous amantadine therapy, for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease (PD). It has completed Phase II proof-of-concept study of ADS-5102 in these patients. Its Phase III clinical program included three placebo-controlled trials: EASED, EASE LID and EASE LID 3. Its second product candidate is ADS-4101, an extended-release version of single-agent compound for the treatment of epilepsy (partial onset seizures).