According to Parkinson’s News Today, the FDA is reviewing Gocovri as a potential treatment for “off episodes” in patients with Parkinson’s disease who are already taking levodopa. “Off episodes” occur when patients on levodopa experience movement symptoms or symptom worsening. Adamas Pharmaceutical, the developer of Gocovri, hope that treating patients with both will prevent these episodes.
Gocovri
The Application
Adamas Pharmaceutical submitted a supplemental new drug application (sNDA) to the FDA, which is expected to have a decision by February 1, 2021. According to the FDA, a New Drug Application (NDA) is filed to achieve approval for a drug to be marketed and sold. Through the NDA, the FDA determines:
whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks; the drug’s proposed labeling is appropriate and what it should contain; [and] whether the methods used in manufacturing…and the controls used to maintain the quality are adequate [in preserving] identity, strength, quality, and purity.
The supplemental new drug application (sNDA) asks the FDA to consider whether off-label drug uses can be described as on-label.
Gocovri for “Off Episodes”
Gocovri (amantadine) is already the sole approved treatment for dyskinesia in patients with Parkinson’s disease who are taking levodopa. Dyskinesia is described as uncontrolled and involuntary muscle movements.
According to an article from StatPearls Publishing, levodopa is the precursor to dopamine. As a result, many patients receive it as dopamine replacement therapy.
However, patients may still experience “off episodes,” where symptoms worsen or suddenly reappear. These usually occur with prolonged levodopa use, which reduces the medication’s efficacy.
In EASE LID and EASE LID 3, researchers discovered that Gocovri successfully reduced dyskinesia, the frequency of off episodes, and the length of off episodes. EASE LID 2, which studied patients over a 2-year period, found that Gocovri was safe, effective, and well-tolerated. Additionally, it found similar results to the prior trials: that Gocovri reduced dyskinesia and the frequency and length of off episodes. Side effects may include dry mouth, dizziness, constipation, low blood pressure, and hallucinations.
Patients on levodopa would take Gocovri near bedtime. This would allow patients to take their levodopa dose in the morning and remain effective throughout the day, while Gocovri would handle nighttime safety.
Learn more about Gocovri here.
Parkinson’s Disease
Parkinson’s disease is a progressive central nervous system disorder which impacts and inhibits movement. It develops when dopamine-producing (dopaminergic) neurons in the brain degenerate and die. Since dopamine helps communication between the brain and muscles, the loss of these neurons cause issues with motor function. Most people who develop Parkinson’s disease are 50 years old or older.
Parkinson’s disease occurs in five stages. The first is mild, with only light tremors on one side of the body. However, by the fifth stage, most patients are unable to live on their own, stand, or walk. Symptoms (throughout all stages) include:
- Stiff and rigid muscles
- Changes in speech, such as slurring, stuttering, or talking too quickly
- Bodily tremors, particularly in the hands
- Slowed and impaired movement, balance, and posture
- Inability to smile or blink
- Hallucinations (in the 5th stage)
Learn more about Parkinson’s disease here.
