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Safety

POOLED SAFETY ANALYSIS OF 2 DOUBLE-BLIND STUDIES

ONGENTYS WAS GENERALLY WELL TOLERATED IN CLINICAL STUDIES1

ADVERSE REACTIONS ≥2% IN PATIENTS TAKING ONGENTYS AND GREATER THAN PLACEBO IN STUDIES 1 AND 21

Adverse ReactionPlacebo, %
(n=257)		ONGENTYS 50 mg, %
(n=265)
Dyskinesia620
Dizziness13
Constipation26
Dry mouth13
Hallucination*13
Insomnia23
Blood creatine kinase increased25
Weight decreased04
Hypotension/
syncope†		15
Hypertension23
  • Following approval, infrequent falls by patients on ONGENTYS have been reported, but a causal relationship with ONGENTYS use has not been established1
  • Discontinuation rates for the double-blind period due to AEs were 8% for patients taking ONGENTYS and 6% for patients taking placebo1
  • The most common adverse reaction leading to discontinuation was dyskinesia, reported in 3% of patients taking ONGENTYS and 0.4% of patients taking placebo1
  • In an exploratory post hoc analysis, patients with early motor fluctuations (≤1 year) had approximately half the risk of experiencing dyskinesia compared with patients with motor fluctuations for a year or longer2‡

Most dyskinesia events were mild or moderate with ONGENTYS (19% of 20%) compared with placebo (5% of 6%).3 Most dyskinesia occurred during the initial 3-week adjustment period of levodopa4

Includes hallucinations, hallucinations visual, hallucinations auditory, and hallucinations mixed.1

Includes hypotension, orthostatic hypotension, syncope, and presyncope.1

Rates of dyskinesia with placebo vs ONGENTYS 50 mg were 2.8% vs 11.8% in patients with early motor fluctuations and 8.0% vs 23.5% in patients with longstanding motor fluctuations.2

AE=adverse event.

POOLED SAFETY ANALYSIS OF 2 DOUBLE-BLIND STUDIES: ADDITIONAL ADVERSE REACTIONS

RATES OF URINE DISCOLORATION AND DIARRHEA WITH ONGENTYS WERE LOW AND COMPARABLE TO PLACEBO3

ADDITIONAL ADVERSE REACTIONS OBSERVED IN THE DOUBLE-BLIND PHASES OF STUDIES 1 AND 2

Adverse ReactionPlacebo, %
(n=257)		ONGENTYS 50 mg, %
(n=265)
Urine discoloration0.00.0
Depressive symptom0.00.0
Depressed mood0.40.4
Depression1.21.1
Impulse control disorders0.01.1
Fatigue1.91.9
Somnolence1.91.9
Sleep attacks and somnolence3.51.9
Diarrhea1.92.3
Nausea3.93.0
Fall4.73.0
Headache4.73.8

Simple, once-daily dosing1

EXPLORE DOSING

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. Ebersbach G, Rascol O, Ferreira JJ, et al. Efficacy and safety of opicapone in Parkinson’s disease patients according to duration of motor fluctuations: post-hoc analysis of BIPARK-I and II. Poster presented at: Congress of the European Academy of Neurology (EAN); May 23-26, 2020; Paris, France.
  3. Data on file. Amneal Pharmaceuticals LLC.
  4. Lees A, Ferreira JJ, Rocha JF, et al. Safety profile of opicapone in the management of Parkinson’s disease. J Parkinsons Dis. 2019;9(4):733-740.