Adamas announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ADS-5102 (amantadine hydrochloride) extended-release capsules, to potentially treat levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease (PD).
ADS-5102, a chrono-synchronous amantadine therapy, was granted orphan drug status for this indication in April 2015. LID episodes occur frequently during waking hours when movement control is needed most. With bedtime dosing, the amantadine plasma concentrations rise slowly during the night to avoid sleep disturbance. Peak and plateau are achieved from early morning to mid-day, declining in the late afternoon and evening.
The NDA submission is based on data from three placebo-controlled trials: EASED, EASE LID and EASE LID 3. The three trials included a total of 286 LID patients with PD, 121 of which received a 340mg dose of ADS-5102 once daily at bedtime.The trials met their primary and key secondary endpoints.
The NDA will also be supported by an ongoing study: EASE LID 2, an open label study with patients from the three previous trials and additional LID patients who have undergone deep brain stimulation.
If approved, ADS-5102 will become the first approved drug to treat LID in the United States.
For more information visit Adamaspharma.com.