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14-week Data

SIGNIFICANT REDUCTIONS IN DAILY OFF TIME AT 14/15 WEEKS WITH A REDUCTION SEEN AS EARLY AS 1 WEEK1,2

In two ~14-week, double-blind studies of patients with PD taking ONGENTYS® (opicapone) capsules + levodopa/DDCI1*:

REDUCED DAILY OFF TIME1,2

Once-daily ONGENTYS significantly reduced off time by 1.95 hours compared to 0.93 hours with placebo (P=0.002) at Week 14/151

BIPARK 1 Study 1 14-Week Efficacy Graph showing LS mean (+ / -) change from baseline (hours) through 14-15 weeks BIPARK 1 Study 1 14-Week Efficacy Graph showing LS mean (+ / -) change from baseline (hours) through 14-15 weeks

Adjusted P value was calculated using a gatekeeping procedure controlling for multiplicity.1

*82% of patients in both groups were also taking concomitant PD medications in addition to levodopa/DDCI, including dopamine agonists (68%), amantadine (23%), MAO-B inhibitors (20%), and anticholinergics (5%).1

DDCI=dopa decarboxylase inhibitor; LS=least squares; MAO=monoamine oxidase; PD=Parkinson’s disease; SE=standard error.

Started to reduce off time as early as 1 week (-1.24 hours vs. -0.42 hours for placebo)2

REDUCED DAILY OFF TIME1,2

Once-daily ONGENTYS significantly reduced off time by 1.98 hours compared to 1.07 hours with placebo (P=0.008) at Week 14/151

BIPARK 2 Study 2 14-Week Efficacy Graph showing LS mean (+ / -) change from baseline (hours) through 14-15 weeks BIPARK 2 Study 2 14-Week Efficacy Graph showing LS mean (+ / -) change from baseline (hours) through 14-15 weeks

Adjusted P value was calculated using Dunnett's alpha level adjustment to control for multiplicity.1

*85% of patients taking ONGENTYS and 81% of patients taking placebo were also taking concomitant PD medications in addition to levodopa/DDCI, including dopamine agonists (70%), amantadine (21%), MAO-B inhibitors (20%), and anticholinergics (12%).1

DDCI=dopa decarboxylase inhibitor; LS=least squares; MAO=monoamine oxidase; PD=Parkinson’s disease; SE=standard error.

Started to reduce off time as early as 1 week (-1.22 hours vs. -0.47 hours for placebo)2

Long-term Studies

INCREASED GOOD ON TIME—WITH MINIMAL CHANGES TO LEVODOPA/DDCI DOSING THROUGH 1 YEAR1,2

In the 1-year open-label extensions of the double-blind studies2:

INCREASED GOOD ON TIME2

BIPARK 1 Study 1 Long-Term Graph showing mean change from double-blind baseline (hours) through 1 year BIPARK 1 Study 1 Long-Term Graph showing mean change from double-blind baseline (hours) through 1 year
  • A mean 2.00-hour reduction in daily off time from double-blind baseline was seen for ONGENTYS (N=98) at Week 52.2*
  • In the open-label period, patients who switched from entacapone to ONGENTYS had almost 45 minutes additional increase in good on time2
  • Though dosing could have been adjusted through Week 46 as needed, 74% of patients taking ONGENTYS (N=98) were able to continue on the same dose of levodopa/DDCI between the open-label baseline and Week 522
  • ~91% of patients who completed the double-blind study (N=542) chose to enroll in the 1-year open-label extension period—with ~87% staying on through the end of 1 year2

*Includes patients who were on ONGENTYS 50 mg in the double-blind period and continued on ONGENTYS in the open-label extension with dosing per the study design.2

DDCI=dopa decarboxylase inhibitor.

INCREASED GOOD ON TIME2

BIPARK 2 Study 2 Long-Term Graph showing mean change from double-blind baseline (hours) through 1 year BIPARK 2 Study 2 Long-Term Graph showing mean change from double-blind baseline (hours) through 1 year
  • A mean 2.64-hour reduction in daily off time from double-blind baseline was seen for ONGENTYS (N=118) at Week 52.2*

No levodopa/DDCI dosing changes for the majority of patients through 1 year2

  • Though dosing could have been adjusted through Week 46 as needed, 70% of patients taking ONGENTYS (N=118) were able to continue on the same dose of levodopa/DDCI between the open-label baseline and Week 522
  • ~98% of patients who completed the double-blind study (N=376) chose to enroll in the 1-year open-label extension period—with ~78% staying on through the end of 1 year2

*Post-hoc analyses. Good on time data from the open-label extension period is presented (based on pre-specified Last Observation Carried Forward analysis approach) broken down by visit by dose.2

Includes patients who were on ONGENTYS 50 mg in the double-blind period and continued on ONGENTYS in the open-label extension with dosing per the study design.

Post-hoc analyses.

DDCI=dopa decarboxylase inhibitor.


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Clinical Overview

ROUND OUT THE TRIO—WITH THE POWER OF
two Phase 3 studies1,2

STUDY 1 DESIGN2

BIPARK 1 Study 1 Study Design Graphic showing the core strategy for the double-blind, randomized, Phase III study and its open-label extension BIPARK 1 Study 1 Study Design Graphic showing the core strategy for the double-blind, randomized, Phase III study and its open-label extension

*Investigators were able to adjust ONGENTYS dose (5, 25, 50 mg) based on clinical response.2

Primary Endpoint

  • Mean change in off time based on 24-hour patient diaries completed 3 days prior to each of the scheduled visits1

Key Secondary Endpoints

  • Off time responders: 1 hour or more reduction in absolute off time from baseline to endpoint2
  • On time responders: 1 hour or more increase in absolute on time from baseline to endpoint2
  • Another secondary endpoint was change from baseline in absolute and percentage of good on time, defined as on time without troublesome dyskinesia.2

AE=adverse event; D=day; DDCl=dopa decarboxylase inhibitor; OL=open-label; PSV=post-study visit; V=visit.

STUDY 2 DESIGN2

BIPARK 2 Study 2 Study Design Graphic showing the core strategy for the double-blind, randomized, Phase III study and its open-label extension BIPARK 2 Study 2 Study Design Graphic showing the core strategy for the double-blind, randomized, Phase III study and its open-label extension

*Investigators were able to adjust ONGENTYS dose (25, 50 mg) based on clinical response.2

Primary Endpoint

  • Mean change in off time based on 24-hour patient diaries completed 3 days prior to each of the scheduled visits1

Key Secondary Endpoints

  • Off time responders: 1 hour or more reduction in absolute off time from baseline to endpoint2
  • On time responders: 1 hour or more increase in absolute on time from baseline to endpoint2

Another secondary endpoint was change from baseline in absolute and percentage of good on time, defined as on time without troublesome dyskinesia.2

AE=adverse event; D=day; DDCl=dopa decarboxylase inhibitor; OL=open-label; PSV=post-study visit; V=visit.

Inclusion criteria2

PD Diagnosis

  • Aged 30 to 83 years (inclusive) who had a diagnosis of idiopathic PD (per the United Kingdom PD Society Brain Bank Clinical Diagnostic Criteria) for at least 3 years
  • Disease severity of Stage 1 to 3 (Modified Hoehn and Yahr scale) during on state

Levodopa/DDCI Treatment

  • Treated with levodopa/DDCI for at least 1 year with clear clinical improvement
  • On a stable regimen of 3 to 8 daily doses of levodopa/DDCI (which could have included a slow-release formulation) and other anti-PD drugs for at least 4 weeks before screening

Signs of Off Time

  • Despite optimal PD therapy (based on the investigator’s judgment), have signs of “wearing off” phenomenon (ie, end-of-dose deterioration) for at least 4 weeks before screening
  • Average total daily off time while awake of at least 1.5 hours (excluding pre-first dose off) based on patient-recorded PD diaries

Exclusion criteria2

Exclusion Criteria Table showing key criteria for patient exclusion in Study 1 and Study 2 Exclusion Criteria Table showing key criteria for patient exclusion in Study 1 and Study 2

*During the study, entacapone other than supplied from the investigator for the study was prohibited.2

DDCI=dopa decarboxylase inhibitor; DSM=Diagnostic and Statistical Manual of Mental Disorders; ECG=electrocardiogram; MAO=monoamine oxidase; NMS=neuroleptic malignant syndrome; PD=Parkinson's disease; UPDRS=Unified Parkinson's Disease Rating Scale.

POOLED STUDY PARTICIPANT DEMOGRAPHICS2

Demographics Table showing pooled study participant demographics for Study 1 and Study 2 Demographics Table showing pooled study participant demographics for Study 1 and Study 2
  • In the pooled analysis, consistent improvement was seen regardless of demographic characteristics, PD severity , and concomitant PD treatments.2

MAO=monoamine oxidase; PD=Parkinson’s disease; SD=standard deviation; UPDRS=Unified Parkinson’s Disease Rating Scale.


Generally well tolerated in
clinical studies

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.