New Drug for Parkinson's Disease Approved by FDA

The US Food and Drug Administration (FDA) recently passed a new drug called amantadine extended release capsules to treat dyskinesia in those who have Parkinson’s disease and  are also on medication therapy. The Michael J. Fox Foundation recently created the UNDRS or Unified Dyskinesia Rating Scale to help measure the impact drugs have during trials.

The new medication and what it means

GOCOVRI is a new high 274 mg dosage of amantadine that is taken once daily at bedtime. It works by consistently delivering high levels of amantadine throughout the day, offering better control of dyskinesia as it occurs. Dyskinesia is a term for a group of symptoms related to Parkinson's disease. Essentially, in dyskinesia, a person experiences involuntary and non-rhythmic movements or tremors. This symptom affects people diagnosed with Parkinson’s disease on a daily basis and prevents most from completing daily activities.

“Dyskinesia can significantly compromise quality of life for people with Parkinson's disease," said Dr. Todd Sherer, Chief Executive Officer of The Michael J. Fox Foundation for Parkinson's Research. "We are pleased that patients have another option to manage this aspect of the disease and glad the Unified Dyskinesia Rating Scale - a tool our support helped develop and validate - could show clinical efficacy of GOCOVRI for the treatment of dyskinesia."

Side effects of the medication

Like other drugs, GOCOVRI is not free of unwanted side effects. However, researchers believe that its positive affects on Parkinson’s disease patients may outweigh the negative side effects associated with the use of GOCOVRI. Some of its potential side effects may include:

• Falling asleep during daily activities: Many treated Parkinson's patients have reported falling asleep and a complete loss of energy during there daily lives.

• Dizziness and Orthostatic Hypotension: Patients using the drug GOCOVRI can often feel dizzy or report feelings lightheaded or faint upon standing, a side effect that is often caused by a sudden decrease in blood pressure upon an abrupt change in position.

• Hallucinations/Abnormal behavior: Patients who suffer from mental instability should not take high doses of amantadine because of the risk of recurring psychotic episodes. Hallucinations may occur during the use of Parkinson's medications.

• Suicidal behavior and depression: Users of amantadine are at an increased risk of developing suicidal behavior and depression when taking large amounts. Users of this drug must carefully monitor for behavioral changes and notify their doctor of any changes in mood or thoughts or harming oneself or others.

• Fevers and confusion: Abruptly stopping the use of GOCOVRI may raise the seriousness of the Parkinson's disease symptoms or cause agitation, paranoid reactions, anxiety, slurred speech, and a lack of mental functions.

• Impulses and sudden behavior: Users may find that they experience impulsivity resulting in an increase in sexual urges, the urge to gamble, frivolous spending, and binge eating when taking this medication.

Test trials of amantadine

Three trials have been conducted on GOCOVRI for Parkinson’s patients. The results of these three trials have showed a reduction of dyskinesia in this patient population. In the first study, trial patients who received the drug showed a significant and relevant reduction in dyskinesia. Specifically, these patients demonstrated a 37% reduction in dyskinesia according to the Unified Dyskinesia Rating Scale (UNDRS). In the second study, the results were confirmed with a 47% reduction in dyskinesia among Parkinson’s patients.

During two of the aforementioned studies, secondary data was collected that showed amantadine usage increased Parkinson’s patients’ activities span by 3.6-4 hours. Compared to the previous data, which shows a small 0.08-2.1 hours of functioning activity time in those patients who are on standard medication therapy, amantadine offers almost 3 hours of extra functional time each day. This means that Parkinson’s patients can increase the amount of time that they spend performing daily activities by 3 hours, which is significant. During each study, the amount of functional time was measured based “on” and “off” time in which the patient either experienced dyskinesia or did not. The studies also found that upon stopping the drug, the symptoms of Parkinson’s began to become visible again in about an hour.

Current medication therapy for Parkinson’s disease

The current medication therapy for Parkinson's patients is levidop/carbidopa. This combination of medicine is utilized to reduce the symptoms of Parkinson's disease. This includes shakiness, stiffness, and difficulty moving. Levodopa essentially develops into dopamine in the brain, which helps control patients movements. Carbidopa prevents the breakdown of levodopa in patients bloodstream, so more levodopa can enter into the brain. Carbidopa is also known to reduce some of levodopa’s side effects which include nausea and vomiting.

This medication is taken by mouth about 3-4 times a day. Taking the medication with food can help with the symptoms and reduce the effect of the levodopa’s side effects. The dosage is based on the medical condition of the patient and their body response to the treatment. Both drugs need to be at the correct strength for each patient, as unbalanced levels can cause further issues. When patients take this medication regularly it would reduce symptoms for a lengthy period of time.

Concluding thoughts

Type of treatment will vary with every patient and the the type may change as the disease develops in patients with Parkinson's disease. Age, work, family, stress, and living situation are all factors that contribute to when and what treatment should be given. For many years doctors have relied on the levidopa/carbidopa medication and it still proven to reduce symptoms significantly.

Recently researchers have been studying if the new GOCOVRI drug will be parallel or better than levidopa/carbidopa. GOCOVRI is referred to as a agonists drug. An agonists drug basically activates the body receptors in the brain, which result in reliving pain. After studying this researchers have concluded that it is dependent on the patients reaction to certain medication and what course of action is best.

One drug is almost a relief from symptoms, while the other activates the pleasure parts in the brain, resulting in an easier time with the disease.  Many researchers have stated that "GOCOVRI's approval is an important advancement for the treatment of Parkinson's disease, as it is the first FDA-approved medicine for the treatment of dyskinesia in Parkinson's disease patients," said Rajesh Pahwa, M.D.