Ongentys® (opicapone) Approved for “Off” Episodes in Parkinson’s Disease

The U.S. Food and Drug Administration (FDA) has approved Ongentys® (opicapone) for people with Parkinson’s disease (PD) who have “off” episodes while taking a medicine called carbidopa/levodopa.¹

An “off” episode is when the medicine is not working as well. During an “off” episode, Parkinson’s motor symptoms like tremors and difficulty walking worsen. This is because the dose of carbidopa/levodopa is wearing off before it is time for the next dose.¹

How does Ongentys work?

The combination of carbidopa and levodopa is currently the most effective treatment available for the management of PD motor symptoms. The body converts levodopa into dopamine and it then crosses the blood-brain barrier to relieve motor symptoms. Carbidopa is added to levodopa to stop levodopa from being converted into dopamine in the blood, allowing more of the medicine to get to the brain.²

Two major enzymes break down levodopa. The enzymes are called DDC and COMT. Carbidopa blocks the DDC enzyme from breaking down levodopa. COMT can still break down some levodopa.³

Ongentys blocks the COMT enzyme from breaking down levodopa. This allows more levodopa to get to the brain.³

Why is this an important approval for people with PD?

There is a significant need for medicines for people with PD who have “off” episodes.

Research shows that within 1 to 2 years, nearly 50 percent of people with PD who take carbidopa/levodopa notice that their medicine does not last as long. This causes symptoms to return before it is time for the next dose.⁴

When people first start taking levodopa, a dose may last 8 hours. Eventually, a dose of levodopa may only last 1 to 2 hours.⁴

When the medicine wears off, many symptoms can occur, including:⁴

• Tremor
• Balance problems
• Anxiety
• Fatigue
• Mood changes
• Restlessness
• Sweating
• Excess saliva

Evidence for Ongentys

The approval of Ongentys was based on the results of 2 clinical trials. The studies looked at 522 people with PD whose symptoms were not well controlled with their regular PD medicine.^3,5

The people in the studies kept a diary of symptoms. Ongentys reduced the “off” time by about 2 hours, compared to placebo (an inactive pill), which was about 1 hour.^3,5

What are the possible side effects of Ongentys?

The most common side effects of Ongentys include:⁵

• Dyskinesia (uncontrolled muscle movement)
• Constipation
• Low blood pressure or fainting
• Weight loss
• An increase in an enzyme called blood creatine kinase

Less common side effects can include:⁵

• Dizziness
• Dry mouth
• Hallucinations
• Trouble sleeping

Some people who take Ongentys fall asleep during everyday activities. Some people have unusual urges, like spending money or binge eating.⁵

These are not all the possible side effects of Ongentys. Talk to your doctor about what to expect or if you experience any changes that worry you.

Things to know about Ongentys

If you take a medicine called a monoamine oxidase inhibitor (MAOI), you should not take Ongentys. If you have a tumor called a pheochromocytoma or paraganglioma, you should not take Ongentys.³

Tell your doctor about any medical conditions you have, including if you:³

• Have daytime sleepiness or any sleep issues
• Have or had intense urges like gambling, binge eating, compulsive shopping, or increased sex drive
• Have a history of uncontrolled sudden movements, hallucinations, or liver or kidney problems

Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding before taking Ongentys.³

Do not drive until you know how Ongentys affects you.

Ongentys may cause hallucinations. You may see, hear, feel, or believe things that are not real or true. Ongentys may cause behavior changes, including unusual urges to spend money, eat, gamble, and have sex. Notify your doctor if you have any of these changes.³

Tell your doctor about any other drugs, vitamins, or supplements you are taking. This includes over-the-counter medicines.

For more information, read the full prescribing information for Ongentys.