The U.S. Food and Drug Administration (FDA) has agreed to review Adamas Pharmaceutical’s application asking that oral Gocovri (amantadine) also be approved to treat off episodes in Parkinson’s disease patients using levodopa.
An FDA decision on the company’s supplemental new drug application (sNDA) is expected by Feb. 1, 2021.
This medication is currently the only treatment approved in the U.S. for dyskinesia — involuntary, jerky movements — in Parkinson’s patients on a levodopa-based therapy, with or without other dopaminergic medications.
Off periods in Parkinson’s are characterized by the reappearance or worsening of symptoms — such as tremors and dyskinesia (involuntary movements) — due to a gradual decline in levodopa’s effectiveness as a therapy.
Gocovri, an extended-release capsule therapy taken daily at night, has been studied in several Phase 3 trials, whose data supported the company’s sNDA. Two of these, EASE LID (NCT02136914) and EASE LID 3 (NCT02274766), showed that Gocovri can effectively reduce the number and duration of off periods, as well as dyskinesia in patients under long-term levodopa treatment.
A more recent Phase 3 trial — the open-label EASE LID 2 (NCT02202551) study — evaluated the long-term safety, tolerability, and effectiveness of Gocovri in Parkinson’s patients with levodopa-induced dyskinesia for two years. It enrolled participants from the two previous EASE trials, as well as patients who underwent deep brain stimulation (DBS) surgery.
Results again confirmed the efficacy of Gocovri in reducing dyskinesia and off episodes in all groups of patients.
The trials have also established Gocovri’s safety, with the most common side effects associated with its use including hallucinations, dizziness, dry mouth, constipation, falls, and low blood pressure when getting up from a sitting or lying position.
“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,” Neil F. McFarlane, chief executive officer of Adamas, said in a press release.
“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,” he added.
Taken at bedtime, Gocovri levels rise slowly overnight and achieve their peak in the morning — before the patient’s first levodopa dose — helping to maintain that treatment’s effectiveness throughout the day.
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