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New Parkinson’s Drug Submitted for FDA Review
A new drug application (NDA) has been submitted to the FDA for ADS-5102 (amantadine hydrochloride) extended-release capsules for the potential treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease (PD). The FDA granted orphan drug status to ADS-5102 for this indication in April 2015.
ADS-5102, a chrono-synchronous amantadine therapy, 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, according to the drug’s developer (Adams Pharmaceuticals). ADS-5102 is also being investigated for the treatment of walking impairment in patients with multiple sclerosis.
The NDA for ADS-5102 was supported by efficacy and safety data from three placebo-controlled clinical studies in a total of 286 PD patients with LID. All of the trials met their primary and key secondary endpoints. In addition, the NDA was supported by data from an ongoing, open-label safety study in which patients are being followed for up to two years.
PD is a chronic neurodegenerative disorder affecting nearly one million people in the United States. The disease is characterized by the progressive loss of dopaminergic neurons, which causes lower levels of endogenous dopamine. This, in turn, manifests as bradykinesia, rigidity, impaired walking, tremor, and postural instability.
Levodopa is considered the “gold standard” for treating all stages of PD. As a result of PD progression and chronic levodopa therapy, nearly all PD patients experience LID, depending on their levodopa dose. LID is characterized by involuntary movements that are nonrhythmic, purposeless, and unpredictable.
Source: Adamas Pharmaceuticals; October 27, 2016.