Ongentys

Treatment for Parkinson's Disease

Ongentys is prescribed for adults with Parkinson's disease to help manage symptoms during "off" episodes. It is not used as a standalone treatment; instead, it is taken in combination with levodopa and carbidopa.

Managing "Off" Episodes

People with Parkinson's disease often take levodopa and carbidopa to control their symptoms. Over time, the effects of these medications may wear off before it is time for the next dose. These periods are known as "off" episodes, during which symptoms may return or worsen. These symptoms often include:

• Muscle stiffness
• Tremors or shaking
• Difficulty moving or walking
• Slowed movement

Ongentys belongs to a class of medications called COMT inhibitors. It works by blocking an enzyme that breaks down levodopa in the body. By helping levodopa last longer, Ongentys can reduce the total amount of "off" time experienced throughout the day and increase "on" time, when symptoms are better controlled.

Mechanism of Action

Ongentys is a type of medication known as a catechol-O-methyltransferase (COMT) inhibitor. It is designed to be used alongside levodopa and carbidopa to help manage Parkinson's disease symptoms more effectively.

Supporting Levodopa

Levodopa is a primary treatment for Parkinson's, but the body naturally produces enzymes that break it down. One of these enzymes is COMT. When COMT breaks down levodopa in the bloodstream, less of the medication is able to reach the brain, where it is needed to produce dopamine.

Reducing Off Episodes

Ongentys works by blocking the COMT enzyme. This action results in several key effects:

• Slower Breakdown: It slows the rate at which the body processes levodopa.
• Higher Concentration: It maintains a more consistent and higher level of levodopa in the blood.
• Extended Relief: By keeping levodopa active for longer, Ongentys helps reduce off periods, which are times when Parkinson's symptoms return because medication levels have dropped too low.

Common Side Effects

The most frequently reported side effects of Ongentys include:

• Dyskinesia: Uncontrolled or involuntary body movements.
• Digestive issues: Constipation and dry mouth.
• Dizziness: Feeling lightheaded, especially when standing up.
• Weight changes: Unintentional weight loss.
• Urinary changes: Presence of blood in the urine.

Serious Side Effects

Some side effects can be severe and should be reported to a healthcare provider immediately:

• Mental health changes: Hallucinations (seeing or hearing things that are not there), confusion, agitation, or psychotic behavior.
• Impulse control disorders: Intense and uncontrollable urges to gamble, increased sexual urges, binge eating, or compulsive spending.
• Extreme sleepiness: Falling asleep suddenly during daily activities, such as eating or talking, sometimes without warning.
• Low blood pressure: Significant drops in blood pressure (orthostatic hypotension) that may lead to fainting or severe dizziness.
• Severe movement problems: A significant worsening of dyskinesia or muscle stiffness.

If you experience a high fever, stiff muscles, or changes in consciousness after stopping or reducing your dose, seek emergency medical care, as these may be signs of a serious reaction.

Contraindications

Ongentys is not recommended for individuals with certain medical conditions or those taking specific medications, including:

• History of catecholamine-secreting tumors, such as pheochromocytoma or paraganglioma, due to the risk of severe increases in blood pressure.
• Current use of non-selective monoamine oxidase (MAO) inhibitors, such as phenelzine, tranylcypromine, or isocarboxazid.

Falling Asleep During Daily Activities

There have been reports of patients falling asleep suddenly while performing daily activities, including driving, without prior warning or feelings of drowsiness. Caution is advised when engaging in activities that require mental alertness.

Dyskinesia and Movement Issues

Because Ongentys increases the levels of levodopa in the body, it may cause or worsen involuntary muscle movements (dyskinesia). A healthcare provider may need to adjust the dosage of levodopa if these symptoms occur or intensify.

Hallucinations and Psychotic Behavior

This medication can cause hallucinations, delusions, agitation, or aggressive behavior. Patients with a pre-existing major psychotic disorder generally should not use Ongentys because of the risk of worsening their condition.

Impulse Control and Compulsive Behaviors

Some patients may experience intense, uncontrollable urges to gamble, increased sexual urges, binge eating, or compulsive spending while taking medications that increase dopamine effects.

Low Blood Pressure and Fainting

Ongentys may cause orthostatic hypotension, which is a sudden drop in blood pressure when standing up. This can lead to dizziness, lightheadedness, or fainting, especially during the early stages of treatment.

Discontinuation Risks

Abruptly stopping or rapidly reducing the dose of medications that affect dopamine can lead to a serious symptom complex resembling neuroleptic malignant syndrome. Symptoms may include high fever, muscle stiffness, and confusion.

Other Precautions

Ongentys is not recommended for use in patients with severe liver impairment or end-stage renal disease, as the safety and effectiveness have not been established in these populations.

Pregnancy

It is currently unknown if Ongentys can cause harm to an unborn baby, as there are no adequate or well-controlled studies in pregnant women. In animal studies, high doses of the medication were associated with adverse effects on fetal development. Because of these uncertainties, it is important to discuss the potential risks and benefits with a healthcare provider if you are pregnant or planning to become pregnant.

Breastfeeding

It is not known whether Ongentys passes into human breast milk or how it might affect a nursing infant. Animal studies have shown that the drug can be present in milk, but human data is unavailable. If you are breastfeeding or planning to breastfeed, consult with a healthcare professional to determine the safest course of action for you and your baby.

Dosage Forms

Ongentys is supplied in the following form for oral administration:

• Oral capsule

FDA Approval and Indication

The U.S. Food and Drug Administration (FDA) approved Ongentys (opicapone) in 2020. It is indicated for patients with Parkinson’s disease who are experiencing "off" episodes, which are periods when the effects of levodopa and carbidopa wear off and motor symptoms return.

Regulatory Classification

Ongentys belongs to a class of drugs known as catechol-O-methyltransferase (COMT) inhibitors. It is a prescription-only medication and is not classified as a controlled substance. At this time, there are no boxed warnings or Risk Evaluation and Mitigation Strategy (REMS) programs required by the FDA for its use.

Safety Warnings and Precautions

The FDA-approved labeling includes several important safety considerations for patients and healthcare providers. These regulatory warnings include:

• Dyskinesia: Ongentys may cause or worsen involuntary muscle movements (dyskinesia) because it increases the effects of levodopa.
• Hallucinations and Psychosis: Patients may experience hallucinations, confusion, or psychotic behavior while taking this medication.
• Impulse Control: There are reports of patients experiencing intense urges, such as compulsive gambling or increased sexual urges, while taking Parkinson's medications like Ongentys.
• Somnolence: The medication can cause extreme sleepiness or episodes of falling asleep suddenly during daily activities.

Regulatory guidelines also state that Ongentys should not be used by patients with certain medical conditions, such as pheochromocytoma or paraganglioma, or by those taking non-selective monoamine oxidase (MAO) inhibitors.

Insurance and Out-of-Pocket Costs

The amount you pay for Ongentys is primarily determined by your insurance plan. Most commercial insurance and Medicare Part D plans provide coverage for this medication, though it is often placed on a higher cost tier. This classification may result in higher copays or coinsurance. Some insurance providers may also require prior authorization, a process where your healthcare provider must justify the medical necessity of the drug before the insurer will cover it.

Financial Assistance

Financial support options may be available to help reduce the cost of Ongentys. The manufacturer offers a savings card for eligible patients with commercial insurance, which can lower monthly out-of-pocket expenses. For individuals who are uninsured or meet specific financial criteria, patient assistance programs may provide the medication at a reduced cost or for free.

Generic Availability

Ongentys is currently available only as a brand-name medication. There is no generic version of opicapone available in the United States. Brand-name drugs typically have higher costs than generics because they are protected by patents that prevent other companies from producing the same medication for a set period.

Pharmacy Variations

The retail price of Ongentys can vary between different pharmacies. Factors such as the pharmacy's location and whether you use a mail-order service can influence the final price. It is often helpful to compare costs at different pharmacies or check for available coupons that may be used by those paying without insurance.