Parkinson’s disease is a chronic, degenerative neurologic disorder affecting close to 1 million people in the United States. Parkinson’s disease 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 gait, tremor and postural instability.
As a replacement therapy for the loss of dopaminergic neurons levodopa is the most effective therapy for Parkinson’s disease and is considered the “gold standard.” Patients on levodopa initially receive relief from symptoms for much of the day – known as ON time. When symptoms return, this is commonly referred to as OFF time. Early in their treatment journey, their daily levodopa regimen is highly effective in maximizing their ON time and minimizing their OFF time during waking hours.
While levodopa-induced dyskinesia (LID) can occur shortly after levodopa initiation in some patients, for approximately 90 percent, it will eventually develop within 10 years after levodopa use. In the United States, we estimate that there are about 400,000 Parkinson’s disease patients experiencing OFF, and of those about 150,000 to 200,000 suffer from LID.
The ADS-5102 New Drug Application (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 Parkinson’s disease. The Phase 3 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 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.
The NDA supporting ADS-5102 for the treatment of levodopa-induced dyskinesia in people with Parkinson’s disease is under review by the FDA with a Prescription Drug User Fee Act (PDUFA) action date of August 24, 2017. The FDA has designated that LID in patients with Parkinson’s disease is an orphan disease. There are currently no approved drugs in the United States or Europe for the treatment of LID in patients with Parkinson’s disease.
~1 M PD patients
~400,000 patients with OFF
~150,000-200,000 with LID