Ongentys (opicapone) for Parkinson’s disease
Fact-checked by What is Ongentys for Parkinson’s disease?
Ongentys (opicapone) for Parkinson’s disease is an approved add-on therapy that’s used to enhance symptom control in people using levodopa and carbidopa. It is specifically intended to help reduce off episodes, or the return of symptoms between levodopa doses.
The death of nerve cells that produce dopamine, an important brain signaling molecule, causes Parkinson’s. Without enough dopamine, the brain struggles with everyday functions, leading to the disease’s motor and nonmotor symptoms.
Levodopa is a standard treatment for Parkinson’s that supplies the body with a dopamine precursor that is converted to dopamine when it reaches the brain, helping to replace the deficient chemical. However, over time, the effects of levodopa become less pronounced, leading to off episodes and fluctuations in motor symptoms.
To avoid potential side effects that can occur with increasing levodopa doses, doctors may prescribe add-on medications to inhibit the enzymes that break down levodopa in the bloodstream, namely DOPA decarboxylase (DDC) and catechol-o-methyl transferase (COMT). This helps more levodopa reach the brain and exert a therapeutic effect. Levodopa is commonly combined with the DDC inhibitor carbidopa.
Ongentys works by blocking COMT, and may enhance the effects of a levodopa/carbidopa treatment regimen by further preventing levodopa breakdown before it reaches the brain.
Bial developed the daily COMT inhibitor for Parkinson’s, and sells the medication in Europe. Other companies market Ongentys elsewhere, including Amneal in the U.S.
Therapy snapshot
| Brand name | Ongentys |
| Chemical name | Opicapone |
| Usage | Used as an add-on to levodopa and carbidopa therapy to treat off episodes in Parkinson’s |
| Administration | Oral capsules |
Who can take Ongentys?
In the U.S., Ongentys is approved as an add-on to levodopa and carbidopa for people with Parkinson’s who are experiencing off episodes. It holds similar approvals elsewhere, including the European Union, where the therapy can be used for patients experiencing symptom fluctuations on levodopa and DDC inhibitors.
The prescribing information for Ongentys lists two contraindications, or reasons not to use the medication:
- if the patient is also taking nonselective monoamine oxidase (MAO) inhibitors, a type of antidepressant medication
- if the patient has a history of catecholamine-secreting neoplasms, a class of tumors that affect hormone signaling in the nervous system
Ongentys is also usually not recommended for people who have end-stage kidney disease, severe liver disease, or a history of psychotic disorders. It should be used with caution in people with suspected or diagnosed dopamine dysregulation syndrome, characterized by overuse of dopaminergic Parkinson’s medications and related addictive behaviors.
How is Ongentys administered?
Ongentys is available as oral capsules. The recommended Ongentys dosage is 50 mg, taken once daily at bedtime. Patients should not eat any food for one hour before and at least one hour after taking the medication.
For people with moderate liver problems, a dose of 25 mg daily is recommended.
Ongentys in clinical trials
Data from two placebo-controlled, Phase 3 clinical trials — BIPARK-1 (NCT01568073) and BIPARK-2 (NCT01227655) — supported the approval of Ongentys. The studies collectively involved more than 1,000 adults with Parkinson’s and motor fluctuations who were taking levodopa and a DDC inhibitor.
- In BIPARK-1, participants who received Ongentys at its now-approved daily dose (50 mg) experienced a nearly two-hour reduction in daily off time after about three months — significantly longer than the approximately one-hour reduction observed in the placebo group. Ongentys performed similarly to another COMT inhibitor, Comtan (entacapone), but with fewer daily doses.
- In BIPARK-2, 50 mg Ongentys similarly significantly outperformed a placebo in reducing off time over about three months of treatment.
- A pooled analysis of the two trials showed that decreases in off time were associated with a corresponding increase in on time — that is, the time when motor symptoms are adequately controlled without causing challenging movement-related side effects, known as dyskinesia — without troublesome unwanted movements.
The main part of both trials was followed by a one-year open-label extension, during which all participants received Ongentys. Treatment benefits were maintained among those consistently on 50 mg Ongentys, and improvements were observed among those who switched from a lower dose or the placebo.
Ongentys side effects
The most common side effects associated with Ongentys are:
- dyskinesia
- constipation
- elevated blood levels of creatine kinase enzyme, a marker of muscle damage
- low blood pressure/fainting
- weight loss
Dyskinesia is a side effect of levodopa that Ongentys may exacerbate. Adjusting the levodopa dosage can sometimes help resolve or ease these problems. If low blood pressure or fainting occurs, Ongentys may need to be discontinued or the dose of other medications reduced.
The prescribing information for Ongentys also lists warnings for other potentially serious side effects that warrant careful monitoring:
- excessive drowsiness and falling asleep during everyday activities
- hallucinations or psychotic-like behaviors
- problems with impulse control
If any of these occur, Ongentys may need to be discontinued, or the dose of other dopaminergic treatments may need to be adjusted. Ongentys may also interact with other medications that are broken down by COMT, leading to cardiovascular side effects. Extra monitoring is recommended for people taking such medications.
Patients should only discontinue Ongentys under medical supervision, because uncontrolled treatment withdrawal could lead to high fever and confusion.
Parkinson's News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
