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Adding ONGENTYS® 50 mgto IR CD/LD reduced “Off” timecompared to IR CD/LD alonein two Phase 3 head-to-headstudies

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INTERNATIONAL PARKINSON AND MOVEMENT DISORDER SOCIETY 2025 TREATMENT GUIDELINES

ONGENTYS is the only COMT inhibitor listed as efficacious3

LEARN MORE

ONGENTYS IS AN ADJUNCT THERAPY TO CD/LD THAT MAY REDUCE "OFF" TIME BY OPTIMIZING LEVODOPA1,4

ONGENTYS is a COMT inhibitor that offers1:

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Selective peripheral COMT inhibition

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Prolonged pharmacokinetic effect due to long-lasting COMT inhibition

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Simple, once-daily dosing

  • As carbidopa protects levodopa from the DDC enzyme, ONGENTYS protects levodopa from the COMT enzyme in the periphery1,4-6
  • Distinct from MAO-B inhibitors and dopamine agonists, which don't directly impact levodopa before it reaches the brain1,7-9
  • ONGENTYS contributed to more consistent levels of levodopa by reducing peak-trough fluctuations by 46%2

Explore the science behind the COMT enzyme and ONGENTYS

MECHANISM OF ACTION

Explore the mechanism behind the selective COMT inhibition with once-daily ONGENTYS capsules

Graphic: Mechanism of Action Video thumbnail

PHYSIOLOGY JOURNEY

See the impact of the COMT enzyme and how it can make levodopa’s path to the brain more difficult

Graphic: Mechanism of Disease Video thumbnail

ONGENTYS is the first and only once-daily COMT inhibitor1,10-12

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CD/LD=carbidopa/levodopa; COMT=catechol-O-methyltransferase; DDC=dopa decarboxylase; IR=immediate-release; MAO-B=monoamine oxidase-B; PK=pharmacokinetics.

CD/LD=carbidopa/levodopa;
COMT=catechol-O-methyltransferase;
DDC=dopa decarboxylase; IR=immediate-release; MAO-B=monoamine oxidase-B;
PK=pharmacokinetics.

IMPORTANT INFORMATION

INDICATION & USAGE

ONGENTYS® (opicapone) capsules is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing "Off" episodes.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ONGENTYS is contraindicated in patients with:

  • Concomitant use of non-selective monoamine oxidase (MAO) inhibitors.
  • Pheochromocytoma, paraganglioma, or other catecholamine secreting neoplasms.

WARNINGS & PRECAUTIONS

Cardiovascular Effects with Concomitant Use of Drugs Metabolized by Catechol-O-Methyltransferase (COMT) - Possible arrhythmias, increased heart rate, and excessive changes in blood pressure may occur with concomitant use of ONGENTYS and drugs metabolized by COMT, regardless of the route of administration (including inhalation). Monitor patients treated concomitantly with ONGENTYS and drugs metabolized by COMT.

Falling Asleep During Activities of Daily Living and Somnolence - Patients have reported falling asleep while engaged in activities of daily living, including driving, which may result in accidents. Consider discontinuing ONGENTYS or adjusting other dopaminergic/sedating medications. Advise patients to avoid driving and other potentially dangerous activities.

Hypotension/Syncope - Monitor patients for hypotension and advise patients about the risk for syncope. If necessary, consider discontinuing ONGENTYS or adjusting the dosage of other medications that can lower blood pressure.

Dyskinesia - ONGENTYS may cause or exacerbate dyskinesia. Consider levodopa or dopaminergic medication dose reduction.

Hallucinations and Psychosis - Consider stopping ONGENTYS if these occur. Patients with a major psychotic disorder should ordinarily not be treated with ONGENTYS.

Impulse Control/Compulsive Disorders - Patients may experience intense urges (eg, gambling, sexual, spending money, binge eating) and the inability to control them. It is important for prescribers to ask about the development of new or increased urges. Monitor for occurrence of intense urges and consider discontinuing ONGENTYS if they occur.

Withdrawal-Emergent Hyperpyrexia and Confusion - A symptom complex resembling neuroleptic malignant syndrome can develop with rapid dose reduction or withdrawal of drugs that increase central dopaminergic tone. When discontinuing ONGENTYS, monitor patients and consider adjustment of dopaminergic therapies as needed.

ADVERSE REACTIONS

The most common adverse reactions (incidence at least 4% and greater than placebo) were dyskinesia, constipation, blood creatine kinase increased, hypotension/syncope, and weight decreased.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see ONGENTYS full Prescribing Information.

References:

  1. ONGENTYS [package insert]. Bridgewater, NJ: Amneal Pharmaceuticals LLC; 2025.
  2. Data on file. Amneal Pharmaceuticals LLC.
  3. de Bie RMA, Katzenschlager R, Swinnen BEKS, et al. Update on treatments for Parkinson’s disease motor fluctuations - an International Parkinson and Movement Disorder Society evidence-based medicine review. Mov Disord. Published online March 8, 2025. doi:10.1002/mds.30162
  4. Rocha J-F, Falcão A, Santos A, et al. Effect of opicapone and entacapone upon levodopa pharmacokinetics during three daily levodopa administrations. Eur J Clin Pharmacol. 2014;70(9):1059-1071.
  5. Connolly BS, Lang AE. Pharmacological treatment of Parkinson disease: a review. JAMA. 2014;311(16):1670-1683.
  6. Tambasco N, Romoli M, Calabresi P. Levodopa in Parkinson’s disease: current status and future developments. Curr Neuropharmacol. 2018;16(8):1239-1252.
  7. Fabbri M, Rosa MM, Ferreira JJ. Adjunctive therapies in Parkinson's disease: how to choose the best treatment strategy approach. Drugs Aging. 2018;35(12):1041-1054.
  8. Dézsi L, Vécsei L. Monoamine oxidase B inhibitors in Parkinson's disease. CNS Neurol Discord Drug Targets. 2017;16(4):425-439.
  9. Stocchi F, Torti M, Fossati C. Advances in dopamine receptor agonists for the treatment of Parkinson's disease. Expert Opin Pharmacother. 2016;17(14):1889-1902.
  10. Comtan [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation.
  11. TASMAR [package insert]. Bridgewater, NJ: Valeant Pharmaceuticals North America.
  12. STALEVO [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation.