Ontilyv
Authorised
This medicine is authorised for use in the European Union
opicapone
MedicineHumanAuthorised
Overview
Ontilyv is a medicine used to treat adults with Parkinson’s disease, a progressive brain disorder that causes shaking and muscle stiffness, and slows movement.
Ontilyv is used as an add-on in patients who are having fluctuations in the ability to move while being treated with combination medicines for Parkinson’s disease that contain levodopa and a DOPA decarboxylase inhibitor (DDCI).
Fluctuations happen when the effects of the combination medication wear off and symptoms re-emerge before the next dose is due. They are linked to a reduction in the effect of levodopa. During these motor fluctuations the patient experiences sudden switches between being ‘on’ and able to move, and being ‘off’ and having difficulty moving about. Ontilyv is used when these fluctuations cannot be treated with the standard levodopa‑containing combinations alone.
This medicine is the same as Ongentys, which is already authorised in the EU. The company that makes Ongentys has agreed that its scientific data can be used for Ontilyv (‘informed consent’).
Ontilyv contains the active substance opicapone.
The medicine can only be obtained with a prescription. Ontilyv is available as capsules to be taken by mouth. The recommended dose is 50 mg, taken once a day at bedtime, at least one hour before or after levodopa combination medicines.
For more information about using Ontilyv, see the package leaflet or contact your doctor or pharmacist.
In patients with Parkinson’s disease, the cells in the brain that produce the neurotransmitter dopamine begin to die and the amount of dopamine in the brain decreases. The patients then lose their ability to control their movements reliably. The active substance in Ontilyv, opicapone, works to restore the levels of dopamine in the parts of the brain that control movement and coordination. It enhances the effects of levodopa, a copy of the neurotransmitter dopamine that can be taken by mouth. Opicapone blocks an enzyme that is involved in the breakdown of levodopa in the body called catechol-O-methyl transferase (COMT). As a result, levodopa remains active for longer. This helps to improve the symptoms of Parkinson’s disease, such as stiffness and slowness of movement.
The benefits of Ontilyv in Parkinson’s disease were investigated in two main studies. In the first study, 600 patients with fluctuations were given Ontilyv, entacapone (another medicine for Parkinson’s disease) or placebo (a dummy treatment), in addition to their current levodopa / DDCI combination. This study looked at how well the treatments reduced the time when patients have more difficulty moving about, called ‘off periods’. After 14-15 weeks, off periods were shortened by 117 minutes (almost 2 hours) in patients taking Ontilyv 50 mg, compared with 96 minutes (about 1 and a half hour) in patients taking the comparator medicine entacapone and 56 minutes (less than 1 hour) in patients taking placebo.
In the second study, which also looked at the reduction in off periods, Ontilyv was compared with placebo in 427 patients who were taking a levodopa / DDCI combination. After 14-15 weeks, off periods were shortened by 119 minutes (almost 2 hours) in patients taking Ontilyv 50 mg, compared with 64 minutes in patients taking placebo.
Both studies were extended for one additional year and confirmed the benefits of Ontilyv when used long-term.
In both studies, patients had average off periods of about 6 to 7 hours at the start of the study.
The most common side effects with Ontilyv are disorders of the nervous system (brain and spinal cord). Among these, dyskinesia (difficulty controlling movement) may affect around 2 in 10 people. For the full list of all side effects reported with Ontilyv, see the package leaflet.
Ontilyv must not be used in:
- patients with tumours of the adrenal glands (small glands located on top of the kidneys) such as pheochromocytoma and paraganglioma;
- patients with a history of neuroleptic malignant syndrome (a nervous system disorder usually caused by antipsychotic medicines) or rhabdomyolysis (breakdown of muscle fibres);
- patients taking medicines known as non-selective monoamine oxidase (MAO) inhibitors, except when used to treat Parkinson’s disease.
For the full list of restrictions, see the package leaflet.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Ontilyv’s benefits are greater than its risks and it can be authorised for use in the EU. Ontilyv was shown to be more effective than placebo and at least as effective as the comparator entacapone in reducing off periods in patients with Parkinson’s disease taking levodopa combination medicines. Regarding its safety, Ontilyv was considered to be comparable to other medicines of the same class.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ontilyv have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Ontilyv are continuously monitored. Suspected side effects reported with Ontilyv are carefully evaluated and any necessary action taken to protect patients.
Ontilyv received a marketing authorisation valid throughout the EU on 21 February 2022.
Product information
Latest procedure affecting product information: IB/0006
24/08/2022
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Ontilyv
- Active substance
- opicapone
- International non-proprietary name (INN) or common name
- opicapone
- Therapeutic area (MeSH)
- Parkinson Disease
- Anatomical therapeutic chemical (ATC) code
- N04
- N04BX04
Pharmacotherapeutic group
Anti-Parkinson drugsTherapeutic indication
Ontilyv is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.
News on Ontilyv
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