Gocovri for Parkinson’s Disease

8 min read

Symptoms of Parkinson’s disease can affect your daily life and well-being. Gocovri (amantadine) is a medicine used to manage uncontrolled movements in people taking a medicine called levodopa for Parkinson’s disease. Gocovri is also used to help treat “off” episodes in people with Parkinson’s disease.

The way Gocovri works for treating uncontrolled movements (dyskinesia) and “off” episodes in people with Parkinson’s disease is not fully known; however, its mechanism is thought to be related to its effect on dopamine levels in the brain, which are usually low in people with Parkinson’s disease. Dyskinesia can sometimes happen when someone has taken levodopa for a long time or if dopamine levels become too high. Symptoms of dyskinesia may include twisting, jerking, or other movements that you can’t control.

People with Parkinson’s disease may also experience “off” episodes when the effects of common medicines for Parkinson’s, like levodopa, wear off, which causes symptoms to return or worsen. “Off” times can occur at varying times during the day. Your health care provider can help you manage “off” time by adjusting your medicines and the time when you take them. They may use slower-release medicines that help keep dopamine levels stable or add medicines that boost dopamine levels.

By increasing dopamine levels, Gocovri can help reduce dyskinesia and shorten the duration of “off” time that people with Parkinson’s disease experience.

Gocovri is an oral medicine that should be taken once daily at bedtime. Gocovri can be taken with or without food. 

Gocovri comes as an extended-release capsule that is swallowed whole. If you have difficulty swallowing the capsules, you can open them and mix the contents with a teaspoonful of soft food like applesauce. The mixture should be swallowed right away after mixing without chewing the contents.

Avoid drinking alcohol when you take your dose of Gocovri.

Gocovri was studied in two short-term clinical studies and a long-term study for the treatment of dyskinesia (uncontrolled movements that can be a side effect of levodopa) and as an add-on treatment to levodopa/carbidopa in people with Parkinson’s disease.

Gocovri was compared to a placebo containing no medicine in both short-term studies. People did not know if they were receiving Gocovri or a placebo. People could participate in the studies if they experienced at least one hour of bothersome dyskinesia during the day that affected their functioning. These studies did not require a minimum amount of “off” time to participate. (As explained above, “off” time is when Parkinson’s symptoms worsen and may happen when your Parkinson’s medicine begins to wear off.)

The study included 196 adults with Parkinson’s disease. The following describes the participants when they entered the study:

  • The average age was 64.7 years and ranged from 34 to 82 years.
  • Over half (55.6%) of the participants were men, and the rest were women.
  • On average, people had been taking levodopa for 7.7 years and had been having dyskinesia side effects from it for about four years.
  • The average score on a scale used to rate dyskinesia symptoms was 40.1 (range, 8-76).
  • Overall, the average daily “off” time was reported as 2.8 hours at the beginning of the study.

The researchers later looked at different groups within the study population. In a subset of people with longer “off” times of 2.5 hours or more, the average “off” time was 4.4 hours at the beginning of the study. In a subset of people with shorter “off” times (less than 2.5 hours), the average at the beginning of the study was one hour. 

Outcomes were analyzed for 196 people from the two short-term (12-week) studies. In both studies, the main way researchers measured how well the treatment worked was by looking at changes in dyskinesia from the start of the study to week 12. To determine this, they used a tool that measures dyskinesia in people with Parkinson’s disease called the Unified Dyskinesia Rating Scale (UDysRS). It looks at how bad the movements are, how long they last, and how much they affect daily life. Higher scores indicate more severe dyskinesia. The researchers also looked at changes in “off” time and “on” time without troublesome dyskinesia.

People who completed either short-term study were eligible to continue into the long-term (two-year) study. There were 80 people who completed the long-term study.

In both short-term studies, people treated with Gocovri showed a significant improvement in dyskinesia at week 12 compared with those taking a placebo, based on changes in the average UDysRS total score.

People taking Gocovri saw their UDysRS score decrease by 15.9 points in Study 1 and by 20.7 points in Study 2. In comparison, people taking a placebo decreased their score by 8.0 points in Study 1 and 6.3 points in Study 2. These results show that Gocovri led to a much greater reduction in dyskinesia compared with placebo.

Also, in both Study 1 and Study 2, people taking Gocovri had more good “on” time without troublesome dyskinesia and less “off” time by week 12 than those taking a placebo.

Your results may be different than those seen in studies.

When researchers looked at the results in different subgroups, they saw that Gocovri reduced “off” time in all groups compared to placebo over the 12-week period. People with longer initial “off” times (of at least 2.5 hours) saw a reduction of 1.2 hours, while those with shorter “off” times (less than 2.5 hours) saw a reduction of 0.8 hours. These reductions in “off” time were not associated with an increase in dyskinesia movements.

During the long-term study, the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) was used to assess the severity and progression of Parkinson’s disease. Part 4 of this scale looks at motor fluctuations, which occur when “on” and “off” time alternate throughout the day. Higher scores indicate greater disease severity. In the long-term study, people taking Gocovri had lower average MDS-UPDRS Part 4 motor fluctuation subscores by week 2, which were maintained through week 100. This means that after two weeks of Gocovri treatment, people were less likely to experience “off” motor fluctuations than before starting treatment, and this benefit continued for the rest of the study.

Your results may differ from what was seen in studies. Talk to your health care provider about what to expect while taking Gocovri and how they will measure how well the medicine is working for you.

Some common side effects seen with Gocovri are seeing or hearing things that others do not see or hear (hallucinations), dizziness, dry mouth, swelling of the feet, legs, or hands, constipation, falling, and low blood pressure upon standing (orthostatic hypotension).

Since Gocovri has caused serious mental and behavioral problems in some people, you should pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, and feelings. Your family and caregivers should also help you to watch for these changes. Tell your health care provider right away if you experience any changes in mood, personality, or behavior, or if you have been told by others that you have these symptoms after taking Gocovri.

Dry mouth can also occur while taking Gocovri. To minimize dry mouth, drink water frequently and try to avoid salty or dry foods. Sucking on sugar-free hard candies, ice chips, or sugar-free popsicles can also help boost saliva flow to the mouth. If dry mouth becomes too bothersome, your health care provider may adjust your dose of Gocovri or switch you to another medicine.

Because Gocovri can make you dizzy, it is important not to drive, operate heavy machinery, or do other potentially dangerous activities until you know how Gocovri affects you. Dizziness can also increase your risk of falls and injuries. Be careful walking, climbing stairs, and doing other physical activities when taking Gocovri.

You may experience swelling of the feet, legs, or hands when taking Gocovri. If you notice swelling after taking Gocovri, inform your health care provider; they may adjust your treatment regimen.

To minimize constipation while taking Gocovri, make sure you are drinking enough water, eating enough fiber, and regularly exercising. Over-the-counter (OTC) medicines such as stool softeners (docusate) can help soften your stool, making it easier to pass. Laxatives such as milk of magnesia, mineral oil, or bisacodyl can also help stool to pass. Ask your health care provider or pharmacist which laxative product might be best for you. If constipation is frequent or ongoing while taking Gocovri, let your health care provider know.

In order to minimize low blood pressure upon standing (orthostatic hypotension), make sure you drink plenty of fluids, and when you stand up, avoid standing up quickly from a sitting position. Also, try to avoid crossing your legs when sitting for long periods. Episodes of low blood pressure may be worse when you first start taking Gocovri. If you continue to have low blood pressure upon standing despite using these methods, let your health care provider know.

These are not all of the possible side effects of Gocovri. Contact your health care provider for medical advice about side effects if you are having symptoms that are bothering you. You can also report side effects to the FDA at 800-FDA-1088 (800-332-1088).

Taking Gocovri with other anticholinergic medicines, such as antihistamines or medicines used for overactive bladder or Parkinson’s disease, can increase the anticholinergic side effects of Gocovri and cause dry mouth, constipation, or dizziness. Let your health care provider know of other medicines you are taking with Gocovri so they can monitor you for these side effects.

The amount of Gocovri in the body is affected by how acidic your urine is (pH), which can be influenced by certain medicines and certain medical conditions. Medicines that can affect the pH of the urine are carbonic anhydrase inhibitors (acetazolamide) and sodium bicarbonate (found in some OTC and prescription medicines used for heartburn or stomach problems). Medical conditions such as severe urinary tract infections or renal tubular acidosis (buildup of acid in the blood) can also affect your urine pH. Let your health care provider know about any medical conditions or other medicines you are taking while on Gocovri.

People taking Gocovri should not receive live flu vaccines, as Gocovri may cause the vaccine to not work as well. When you get your yearly flu vaccine, make sure your health care provider is aware that you are taking Gocovri, so they can give you an inactivated flu vaccine, which is not affected by Gocovri.

Avoid drinking alcohol while taking Gocovri, as it increases the risk of dizziness, confusion, lightheadedness, and low blood pressure upon standing (orthostatic hypotension).

This is not a complete list of interactions. Tell your pharmacist or other health care provider about all the prescription or OTC medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken. This will help them know if there are any interactions with Gocovri.

There may be cost assistance available to help you afford Gocovri. Visit www.gocovri.com/savings-and-support or call 844-462-6874 to find out more.