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Why ONGENTYS

Sustained COMT Inhibition

ONGENTYS DELIVERS STRONGER AND MORE SUSTAINED COMT INHIBITION1,2

REDUCED COMT ACTIVITY SUSTAINED OVER 24 HOURS COMPARED WITH ENTACAPONE2,3

Line chart: COMT enzyme activity remained low and stable in patients taking ONGENTYS Line chart: COMT enzyme activity remained low and stable in patients taking ONGENTYS

In one daily dose, ONGENTYS® (opicapone) capsules deliver more sustained inhibition of COMT than entacapone TID2,4,5

CD=carbidopa; COMT=catechol-O-methyltransferase; LD=levodopa; TID=three times a day.

REDUCED LEVODOPA FLUCTUATIONS

ONGENTYS REDUCED LEVODOPA FLUCTUATIONS1,2,6

Patients on once-daily ONGENTYS taking CD/LD every 4 hours experienced:

46%

reduction in levodopa fluctuations3*

  • 230% increase in levodopa trough concentrations and only a 35% increase in peak concentrations, helping maintain smoother peak-to-trough variations3,6

  • Up to 74% increase in total levodopa exposure3

In an open-label, Phase 1 study, patients were randomized to receive immediate-release CD/LD, either every 3 hours (n=7) or every 4 hours (n=9).3

Data for patients receiving immediate-release CD/LD every 3 hours include 109% trough concentration increase and 38% peak concentration increase. All patients received once-daily ONGENTYS capsules 50 mg in the evening from Days 1 to 14.3

*Peak-to-trough variations were calculated as: ([Cmax-Cmin]/Cave) x 100.3

Increased concentrations of levodopa over time1,3

Line chart: ONGENTYS increased levodopa total concentration by up to 74% over 12 hours versus carbidopa/levodopa alone Line chart: ONGENTYS increased levodopa total concentration by up to 74% over 12 hours versus carbidopa/levodopa alone

Sustained COMT inhibition may reduce fluctuations in peak‑to‑trough concentrations of levodopa over time1,3,6

DISCOVER THE DATA

See how ONGENTYS reduced "off" time and increased "good on" time in two Phase 3 studies.

EXPLORE EFFICACY

CD=carbidopa; COMT=catechol-O-methyltransferase; LD=levodopa.

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; 2023.
  2. 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.
  3. Data on file. Amneal Pharmaceuticals LLC.
  4. Kiss LE, Ferreira HS, Torrao L, et al. Discovery of a long-acting, peripherally selective inhibitor of catechol-O-methyltransferase. J Med Chem. 2010;53:3396-3411.
  5. Palma PN, Bonifácio MJ, Loureiro AI, Soares-da-Silva P. Computation of the binding affinities of catechol-O-methyltransferase inhibitors: multisubstate relative free energy calculations. J Comput Chem. 2012;33:970-986.
  6. Brooks DJ. Optimizing levodopa therapy for Parkinson’s disease with levodopa/carbidopa/entacapone: implications from a clinical and patient perspective. Neuropsychiatr Dis Treat. 2008;4(1):39-47.