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news.Adamas Pharmaceuticals has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for ADS-5102 (amantadine hydrochloride) extended-release capsules, the company's lead product candidate, for the potential treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease (PD).
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In April 2015, the FDA granted orphan drug status to ADS-5102 for this indication.
Adamas Pharmaceuticals chairman and CEO Gregory Went said: "The ADS-5102 NDA submission represents a major milestone both for Adamas and for patients with Parkinson's disease who are challenged to complete the tasks of everyday life as a result of LID.
"If approved, ADS-5102 would represent a new approach to treating LID and would be the first drug approved in the United States for this condition. We thank the physicians, patients and caregivers involved in our clinical trials for their pioneering spirit and support in helping us reach this critical milestone."
The ADS-5102 NDA is supported by efficacy and safety data compiled from Adamas' comprehensive registration program, which was designed to evaluate ADS-5102 for the treatment of LID in patients with PD. The clinical program included three placebo-controlled trials: EASED, EASE LID and EASE LID 3.
The three trials enrolled a total of 286 patients, of whom 121 patients received a 340 mg dose of ADS-5102 once daily at bedtime. Both Phase 3 trials met their primary and key secondary endpoints.
In addition, the NDA is supported by data from an open-label safety study known as EASE LID 2 for patients from EASED, EASE LID and EASE LID 3 as well as LID patients who have undergone deep brain stimulation. The EASE LID 2 trial is ongoing, and patients are being followed for up to two years.
About ADS-5102
ADS-5102 is a chrono-synchronous amantadine therapy for the potential treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease (PD). ADS-5102 is dosed once daily at bedtime to time the delivery of drug levels of amantadine to waking hours when LID episodes are most frequent and movement control is needed most.
With bedtime dosing, the amantadine plasma concentrations rise slowly during the night to avoid sleep disturbance, with peak and plateau achieved from early morning to mid-day, declining in the late afternoon and evening. We are also investigating ADS-5102 for the treatment of walking impairment in multiple sclerosis (MS) patients, and we plan to pursue a pivotal registration program for this indication.
Parkinson's Disease and Levodopa-induced Dyskinesia
Parkinson's disease (PD) is a chronic neurodegenerative disorder affecting close to 1 million people in the United States. PD is characterized by the progressive loss of dopaminergic neurons, causing lower levels of endogenous dopamine and manifesting as symptoms of bradykinesia (slowness of movement), rigidity, impaired walking, tremor and postural instability.
Levodopa is the most effective therapy for all stages of PD and is considered the "gold standard." As a result of PD progression and chronic levodopa therapy, nearly all PD patients will experience levodopa-induced dyskinesia (LID) depending on their levodopa dose. LID is characterized by involuntary movements that are non-rhythmic, purposeless and unpredictable.