The Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Gocovri® (amantadine extended-release; Adamas Pharmaceuticals) for the treatment of off episodes in Parkinson disease (PD) patients receiving levodopa-based therapy.
The sNDA submission is supported by data from 2 pivotal, randomized, double-blind, placebo-controlled phase 3 trials that evaluated the efficacy and safety of Gocovri for the treatment of dyskinesia in 196 patients with PD. Results from both studies showed that treatment with Gocovri led to a significant decrease in off time at week 12 from baseline compared with placebo.
A Prescription Drug User Fee Act (PDUFA) action date of February 1, 2021 has been set for this application.
Gocovri is currently approved for the treatment of dyskinesia in PD patients receiving levodopa-based therapy, with or without concomitant dopaminergic medications. The product is supplied as 68.5mg and 137mg strength extended-release capsules in 60-count bottles.
“We are pleased the FDA has accepted our sNDA for review,” said Neil F. McFarlane, CEO, Adamas. “If approved, the indication would reflect the full spectrum of Gocovri’s therapeutic benefit in PD motor complications and better support physicians to identify appropriate treatments for their patients.”
For more information visit adamaspharma.com.