Ongentys (opicapone)

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Ongentys (opicapone)

How to buy Ongentys: You can order Ongentys (opicapone) via TheSocialMedwork if the drug has not been approved and/or is not available in the patient's country. TheSocialMedwork - helping patients and doctors access the latest approved medicines and at the lowest price possible worldwide.

Manufacturer Portela & Ca.
Disease Parkinson's Disease
Indication Parkinson's Disease
Mode of Action COMT inhibitor (dopamine enhancer)
Approval Status EMA approved (EU)
CAS Number 923287-50-7
HS Code 30029090
Strength 50 mg

Who is opicapone for?

Opicapone is indicated for the treatment of adult patients with Parkinson disease. It is used as an add-on to levodopa / DOPA decarboxylase inhibitors (DDCI) (other medicines for Parkinson’s disease) in patients who are having fluctuations in the control of their condition [1].

Recommended dose

  • Complete information about opicapone dosage and administration can be found here [2].
  • The recommended therapy consists of 50 mg, taken once a day at bedtime, at least one hour before or after levodopa combination medicines [1].
  • Consult your treating doctor for personalised dosing.

What is opicapone and how does it work?

Opicapone is a medicine used to treat adults with Parkinson’s disease, a progressive brain disorder that causes shaking and muscle stiffness, and slows movement [1].
Parkinson’s disease develops when neurons (brain cells) in a particular part of the brain stop working properly, and are lost over time. These neurons produce an important chemical called dopamine. Dopamine is used by the brain to send messages across brain areas to help control movement. Eventually the brain cannot make enough dopamine to control the movement properly. There is currently no cure for Parkinson’s Disease. Existing treatments aim to help patients manage symptoms [3].
The active substance in Ongentys—opicapone—works to restore the levels of dopamine in the areas of the brain that control movement and coordination. It enhances the effects of another drug, named levodopa, commonly used to treat Parkinson’s Disease. 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 relieve the symptoms of Parkinson’s disease, such as stiffness and slowness of movement [1].

What is opicapone's approval status?

Opicapone was approved by the European Medicines Agency (EMA) on June 24, 2016, for treating patients with Parkinson’s Disease as an add-on to levodopa / DOPA decarboxylase inhibitors (DDCI) in patients who are having fluctuations in the control of their condition [1].
The benefits of opicapone in Parkinson’s disease were investigated in two main studies. In the first study, 600 patients with fluctuations were given opicapone, 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 ‘off periods' (the time when patients have more difficulty moving about). After 14-15 weeks, ‘off periods’ were shortened by 117 minutes (almost 2 hours) in patients taking opicapone 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, opicapone was compared with a 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 opicapone 50 mg, compared with 64 minutes in patients taking placebo. Both studies were extended for one additional year and confirmed the benefits of opicapone when used long-term [1].
The most common side effects with opicapone are disorders of the nervous system (brain and spinal cord). Among these, dyskinesia (difficulty controlling movement) may affect around 2 in 10 people [1].
References
[1] EMA. Human Medicines: Ongentys (opicapone), 01/07/2016 (last update: 02/02/2017), cited on 09/11/2016.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002790/human_med_001950.jsp&mid=WC0b01ac058001d124
[2] Summary of Product Characteristics [EMA]: Ongentys (opicapone), Bial - Portela & Cª, Feb. 2017.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002790/WC500209536.pdf
[3] Parkinson's UK. Cited on 09/11/2016.
https://www.parkinsons.org.uk/content/treatments-and-therapies-parkinsons








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