FDA discusses Phase III studies of Arimenda (Adamas Pharmaceuticals) for Alzheimers treatment

Adamas Pharmaceuticals has held an end-of-Phase II meeting with the FDA to discuss the proposed safety and efficacy studies to be conducted for the registration of Arimenda (memantine HCl extended release and donepezil HCl) capsules, for treatment of Alzheimers Disease. At the meeting, the FDA agreed to Adamas' Phase III clinical safety studies and confirmed that, if successful, those studies should be sufficient to support a future NDA submission. Arimenda capsules are expected to be the first once-daily fixed dose combination product for Alzheimer's disease available for the US market. The drug is designed to simplify the initiation of combination therapy by providing the most convenient means to introduce combination therapy to patients who are already taking donepezil. Adamas is on track to submit its first NDA for Arimenda in 2013.