Adamas Announces FDA Filing Acceptance of sNDA to Modify Indication Statement for GOCOVRI

Adamas Pharmaceuticals announced 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, Adamas 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.

“We are pleased the FDA has accepted our sNDA for review. 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,” said Neil F. McFarlane, Chief Executive Officer. “Many PD medications necessitate a trade-off between reducing OFF time and exacerbating levodopa-induced dyskinesia. GOCOVRI is the first medication clinically proven to reduce both.”

GOCOVRI® (amantadine) extended-release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine clinically proven to reduce both dyskinesia and OFF. Taken once daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day. Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension.