Why Ongentys

THE IMPACT OF COMT

IS COMT INHIBITION MISSING FROM YOUR CD/LD STRATEGY?

ONGENTYS IS DESIGNED TO WORK WITH CD/LD TO DELIVER MORE LEVODOPA TO THE BRAIN, WHERE IT’S NEEDED^1-4

Levodopa is metabolized by 2 peripheral enzymes, DDC and COMT^1,5,6

Just as carbidopa protects levodopa from the DDC enzyme, ONGENTYS protects levodopa from being metabolized by the COMT enzyme^1,5,6

When left unchecked, the COMT enzyme continues to degrade levodopa—even when the dosage of CD/LD is increased^2,3

PHARMACOKINETICS

In a Clinical Pharmacokinetic Study,

ONGENTYS PROVIDED INCREASED COMT INHIBITION^1,5,7

ONGENTYS INCREASED LEVODOPA CONCENTRATIONS^*†‡

ONGENTYS significantly increased the trough levels (C_min) of levodopa and its systemic extent of exposure (AUC_0-24)

INCREASED COMT iNHIBITION WAS sUSTAINED fOR oVER 24 hOURS cOMPARED wITH enTACAPONE^*†‡

Clinical efficacy claims cannot be drawn on the basis of PK data.¹

A randomized, double-blind, placebo-controlled study in 80 healthy participants that compared the effects of placebo, entacapone, and ONGENTYS to the PK profile of CD/LD. Participants received ONGENTYS 50 mg once daily or placebo for 11 days; on Day 12, they received placebo with each dose of CD/LD. Participants in the entacapone group received placebo once daily for 11 days; on Day 12, they received entacapone 200 mg concomitantly with 3 doses of CD/LD administered 5 hours apart.¹

The data presented are a summary of a descriptive analysis, and no formal statistical comparisons were performed.¹
AUC_0-24=area under the curve from time 0 to 24 hours; C_min=minimum observed plasma concentration; CD/LD=carbidopa/levodopa; COMT=catechol-O-methyltransferase; DDC=dopa decarboxylase; PK=pharmacokinetic.

MEET ROBERT AND AMELIA,
TWO POTENTIAL ONGENTYS PATIENTS

SEE THE PROFILES

Not actual patients.

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:

Rocha JF, 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.
Männistö PT, Kaakkola S. Catechol-O-methyltransferase (COMT): biochemistry, molecular biology, pharmacology, and clinical efficacy of the new selective COMT inhibitors. Pharmacol Rev. 1999;51(4):593-628.
Andersson I, Granerus AK, Jagenburg R, Svanborg A. Intestinal decarboxylation of orally administered L-dopa: influence of pharmacological preparation, dose magnitude, dose sequence and food intake. Acta Med Scand. 1975;198(5):415-420.
Connolly BS, Lang AE. Pharmacological treatment of Parkinson disease: a review. JAMA. 2014;311(16):1670-1683.
ONGENTYS [package insert]. Bridgewater, NJ: Amneal Pharmaceuticals LLC; 2025.
Tambasco N, Romoli M, Calabresi P. Levodopa in Parkinson’s disease: current status and future developments. Curr Neuropharmacol. 2018;16(8):1239-1252.
Data on file. Amneal Pharmaceuticals LLC.

Why Ongentys

IS COMT INHIBITION MISSING FROM YOUR CD/LD STRATEGY?

ONGENTYS PROVIDED INCREASED COMT INHIBITION1,5,7

INCREASED COMT iNHIBITION WAS sUSTAINED fOR oVER 24 hOURS cOMPARED wITH enTACAPONE*†‡

References:

ONGENTYS PROVIDED INCREASED COMT INHIBITION^1,5,7

INCREASED COMT iNHIBITION WAS sUSTAINED fOR oVER 24 hOURS cOMPARED wITH enTACAPONE^*†‡