Memantine ER/donepezil regulatory update

Forest Labs submitted an NDA for a once-daily, fixed-dose combination of memantine extended release (ER) and donepezil to treat moderate to severe dementia of the Alzheimer's type. Forest Labs and Adamas developed the combination under a 2012 deal, under which Forest Labs is responsible for regulatory activities and has exclusive U.S. commercialization rights to the product. Adamas retains exclusive rights outside of the U.S. (see BioCentury, Nov. 19, 2012 & Jan. 20, 2014). The application covers 2 dose strengths: 14 or 28 mg memantine ER plus 10 mg donepezil. ...