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Early Levodopa/Carbidopa Partner

Levodopa & Carbidopa just
aren't the same without ONGENTYS

ONGENTYS® (opicapone) capsules is the early
levodopa/carbidopa partner that enhances levodopa1,2

  • Increased levodopa exposure by up to 74%, helping more levodopa be available to reach the brain1,2
  • Started to reduce off time as early as 1 week,* with significant reductions of 2 hours vs. 1 hour with placebo seen at 14/15 weeks—studied through 1 year1,2
  • No titration required—one capsule, taken at bedtime1
    • Patients should not eat food for 1 hour before and at least 1 hour after taking ONGENTYS1

*At Week 1: -1.24 hours vs. -0.42 hours for placebo in Study 1; -1.22 hours vs. -0.47 hours for placebo in Study 2.2

For Study 1: -1.95 hours vs. -0.93 hours with placebo at Week 14/15 (P=0.002); adjusted P value was calculated using a gatekeeping procedure controlling for multiplicity. For Study 2: -1.98 hours vs. -1.07 hours with placebo at Week 14/15 (P=0.008); adjusted P value was calculated using Dunnett’s alpha level adjustment to control for multiplicity.1

Missing Musketeer Image

Discover an early levodopa/carbidopa partner
Unique Molecule

ONGENTYS is a unique molecule
in COMT inhibition1,3

ONGENTYS® (opicapone) capsules Molecule

Artistic depiction does not represent all characteristics of the ONGENTYS molecule and is provided for illustration purposes only.

COMT=catechol-O-methyltransferase.

  • Once Daily

    ONGENTYS can be taken once daily
    at bedtime1

  • Strong
    Comt-binding affinity

    High COMT-binding affinity,
    which means that ONGENTYS
    has a strong attraction to
    the COMT enzyme1

  • Prolonged
    pharmacologic effect

    Prolonged duration of
    COMT inhibition over the
    24-hour dosing interval1

  • Unique structure

    Unique chemical
    structure1,3

COMT=catechol-O-methyltransferase.

Mechanism of Action Video Thumbnail

Dive into the science behind ONGENTYS

Sustained COMT Inhibition

ONGENTYS IS THE FIRST AND ONLY
ONCE-DAILY COMT INHIBITOR1

Sustained COMT inhibition2,3

COMT Inhibition Graph showing mean COMT enzyme activity (% of baseline) through 24 hours after first levodopa/carbidopa dose COMT Inhibition Graph showing mean COMT enzyme activity (% of baseline) through 24 hours after first levodopa/carbidopa dose
COMT Inhibition vs Entacapone Graph showing mean COMT enzyme activity (% of baseline) through 24 hours after first levodopa/carbidopa dose COMT Inhibition vs Entacapone Graph showing mean COMT enzyme activity (% of baseline) through 24 hours after first levodopa/carbidopa dose

Reduced COMT activity was sustained over a 24-hour period, keeping COMT activity low throughout the day.1,3

ONGENTYS reduced COMT activity, with consistent, sustained COMT inhibition over the once-daily dosing period.3

Entacapone administration 3x/day resulted in short-duration COMT inhibition, with return to near baseline values between doses.3

Sustained 3-OMD reduction2,3

3-OMD Reduction Graph showing mean 3-OMD  plasma concentration (ng/mL) through 24 hours after first levodopa/carbidopa dose 3-OMD Reduction Graph showing mean 3-OMD  plasma concentration (ng/mL) through 24 hours after first levodopa/carbidopa dose

By inhibiting the COMT enzyme, ONGENTYS provided sustained
reduction of 3-OMD.3

3-OMD=3-O-methyldopa; COMT=catechol-O-methyltransferase.

3-OMD=3-O-methyldopa; COMT=catechol-O-methyltransferase.

Increased Levodopa Exposure

ONGENTYS HELPED MAINTAIN HIGHER AND SMOOTHER LEVODOPA CONCENTRATIONS THROUGH DAILY LEVODOPA/CARBIDOPA DOSING INTERVALS1,2

In patients taking levodopa/carbidopa every 4 hours2:

INCREASED LEVODOPA EXPOSURE2

Levodopa Exposure Graph showing increased mean levodopa plasma concentration (ng/mL) through 12 hours after first levodopa/carbidopa dose Levodopa Exposure Graph showing increased mean levodopa plasma concentration (ng/mL) through 12 hours after first levodopa/carbidopa dose

UP TO 74%

Up to 74% increase in total levodopa exposure, which may allow more levodopa to reach the brain1,2

SMOOTHED OUT PEAK-TO-TROUGH VARIATIONS*

ONGENTYS was shown to more than double (110%) levodopa trough concentrations, while increasing peak concentrations by only 35%, helping maintain smoother peak-to-trough variations2,4

In an open-label, Phase 1 study, patients were randomized to receive immediate-release levodopa/carbidopa, either every 3 hours (n=7) or every 4 hours (n=9). Data for Q3H includes 100% trough concentration increase and 38% peak concentration increase. The data for this every-4-hour, or Q4H, population are shown here. All patients received once-daily ONGENTYS 50 mg in the evening from Days 1 to 14.

*Peak-to-trough variations were calculated as: ([Cmax – Cmin]/Cave) × 100.2

VIEW FULL IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY
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 treated with dopaminergic medications and medications that increase levodopa exposure, including ONGENTYS, have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes has resulted in accidents. If a patient develops daytime sleepiness or somnolence, consider discontinuing ONGENTYS or adjusting other dopaminergic or sedating medications and 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 these adverse reactions occur, consider discontinuing ONGENTYS or adjusting the dosage of other medications that can lower blood pressure.

Dyskinesia

ONGENTYS potentiates the effects of levodopa which may result in dyskinesia or exacerbate pre-existing dyskinesia. Reducing the patient’s levodopa dosage or the dosage of another dopaminergic drug may reduce dyskinesia that occurs during treatment with ONGENTYS.

Hallucinations and Psychosis

Consider stopping ONGENTYS if hallucinations or psychotic-like behaviors 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 specifically ask patients or their caregivers about the development of new or increased urges.

Re-evaluate the patient’s current therapies for Parkinson’s disease and consider stopping ONGENTYS if a patient develops such urges while taking ONGENTYS.

Withdrawal-Emergent Hyperpyrexia and Confusion

A symptom complex resembling neuroleptic malignant syndrome (elevated temperature, muscular rigidity, altered consciousness, and autonomic instability) has been reported in association with rapid dose reduction or withdrawal of drugs that increase central dopaminergic tone. There were no reports of neuroleptic malignant syndrome in ONGENTYS controlled clinical studies. When discontinuing ONGENTYS, monitor patients and consider adjustment of other 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]. San Diego, CA: Neurocrine Biosciences, Inc; 2020.
  2. Data on file. Neurocrine Biosciences, Inc.
  3. 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.
  4. 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.