FDA reviewing Adamas' PD candidate

Adamas Pharmaceuticals Inc. (NASDAQ:ADMS) said FDA accepted for review its NDA for ADS-5102 to treat levodopa-induced dyskinesia in Parkinson's disease patients. Its PDUFA date is Aug. 24.

The oral extended-release formulation of amantadine met the primary endpoint in two Phase III studies and a Phase II/III trial (see BioCentury Extra, Sept. 21, 2016)...