Clinical Profile

PRESCRIBING INFORMATION

DOSE & VIAL CALCULATORS

PRODUODOPA Clinical Studies

The efficacy and safety of 24-hour continuous levodopa-based therapy with PRODUODOPA were demonstrated in 2 trials.^1-3

12-Week

Pivotal Phase 3, randomized, double-blind, double-dummy, active-controlled study evaluating the efficacy and safety of 24‑hour daily continuous subcutaneous infusion of PRODUODOPA compared with oral IR levodopa/carbidopa^1,3

Study Design Details

52-Week

Phase 3, single-arm, open-label study evaluating the safety and efficacy of 24-hour daily exposure with a continuous subcutaneous infusion of PRODUODOPA^1,2

Study Design Details

IR=immediate-release.

Study Design
Motor Symptoms

PRODUODOPA 12-Week Efficacy and Safety Study Design^1,3

Aim: Evaluate the efficacy, safety, and tolerability of PRODUODOPA to oral IR levodopa/carbidopa in patients with advanced PD.

Duration: 12 weeks.

Study type: Phase 3, 1:1 randomized, double-blind, double-dummy, active-controlled.

Patient population: Evaluation of 141 patients. The target population was levodopa-responsive patients with advanced PD whose motor symptoms were inadequately controlled with current treatment and experienced minimum daily average of 2.5 hours of “Off” time per day, as assessed by PD diaries.*

Of the 74 patients randomized to receive PRODUODOPA, 48 completed the study and 26 discontinued treatment.

Of the 67 patients receiving optimized oral IR levodopa/carbidopa, 62 completed treatment and 5 discontinued.

*Based on the PD diary, the average daily normalized “On” time for patients on PRODUODOPA was 9.20 (+/-2.42) hours at baseline and increased by 2.72 (+/-0.52) hours at Week 12 compared with an increase of 0.97 (+/-0.50) hours at Week 12 from a baseline of 9.49 (+/-2.62) hours for patients taking optimized IR levodopa/carbidopa (LS mean change [SE]). This resulted in a statistically significant improvement of 1.75 (+/-0.65) hours in patients on PRODUODOPA vs oral IR LD/CD (LS mean of difference [SE]; P=0.0083). Average daily normalized “Off” time for patients on PRODUODOPA was 6.34 (+/-2.27) hours at baseline and decreased by 2.75 (+/-0.50) hours at Week 12 compared with a decrease of 0.96 (+/-0.49) hours at Week 12 from a baseline of 5.91 (+/-1.88) hours for patients taking optimized IR levodopa/carbidopa (LS mean change [SE]). This resulted in a statistically significant improvement of 1.79 (+/-0.63) hours in patients on PRODUODOPA vs oral IR LD/CD (LS mean of difference [SE]; P=0.0054).¹

IR=immediate-release; LD/CD=levodopa/carbidopa; PD=Parkinson’s disease; LS=least squares; SE=standard error.

Note to affiliate: Click through this button to review primary and secondary endpoints from DUODOPA data

See Trial Endpoints

Please refer to the PRODUODOPA SmPC for full study data.

See Trial Endpoints

Please refer to the PRODUODOPA SmPC for full study data.

What Does 24-Hour Continuous Delivery Without Surgery Mean for Your Patients?

Reduction in morning "Off" state (morning akinesia)¹*

Fewer interruptions over 24 hours morning, day, and night^3*

More “On” time and less “Off” time over 24 hours means patients can do more^1†

*Patients recorded their PD symptoms in a PD Diary, which was completed for a full 24-hour period. Patients made an entry upon waking and every 30 minutes during their normal waking time and upon awakening from time asleep. Patients recorded their "On" time without troublesome dyskinesia (sum of "On" time without dyskinesia and "On" time without troublesome dyskinesia) and "Off" time as assessed by the PD Diary.³

^†More refers to improvement for patients on PRODUODOPA compared with oral IR levodopa/carbidopa in “On” and “Off” time at Week 12.³

IR=immediate-release; PD=Parkinson's disease.

PRODUODOPA Provided a Superior Improvement in Good “On” Time vs Oral IR Levodopa/Carbidopa^1,3

12-Week Study

PRODUODOPA Provided a Superior Improvement in Good “On” Time vs Oral IR Levodopa/Carbidopa^1,3

12-Week Study

Change from baseline to Week 12 in “On” time without troublesome dyskinesia*

(LS mean of difference=1.75 hours; P=0.0083)

*Based on the PD diary, the average daily normalized “On” time without troublesome dyskinesia for patients on PRODUODOPA was 9.20 (SD +/-2.42) hours at baseline and increased by 2.72 (SE +/-0.52) hours at Week 12 compared with an increase of 0.97 (SE +/-0.50) hours at Week 12 from a baseline of 9.49 (SD +/-2.62) hours for patients taking optimized IR levodopa/carbidopa (LS mean change [SE]). This resulted in a statistically significant improvement of 1.75 (SE +/-0.65) hours in patients on PRODUODOPA vs oral IR LD/CD (LS mean of difference [SE]; P=0.0083). “On” time without troublesome dyskinesia is the sum of “On” time without dyskinesia and “On” time with non‑troublesome dyskinesia.

^†Model-based least square mean (standard error) of change.

^‡Calculated by dividing the change in hours from baseline by the number of hours reported at baseline.

IR=immediate-release; LS=least squares; PD=Parkinson's disease; SD=standard deviation; SE=standard error; LD/CD=levodopa/carbidopa.

PRODUODOPA Provided a Superior Improvement in Daily “Off” Time vs Oral IR Levodopa/Carbidopa^1,3

12-Week Study

PRODUODOPA Provided a Superior Improvement in Daily “Off” Time vs Oral IR Levodopa/Carbidopa^1,3

12-Week Study

Change from baseline to Week 12 in “Off” time*

(LS mean of difference=-1.79 hours; P=0.0054)

^*Based on the PD diary, the average daily normalized “Off” time for patients on PRODUODOPA was 6.34 (SD +/-2.27) hours at baseline and decreased by 2.75 (SE +/-0.50) hours at Week 12 compared with a decrease of 0.96 (SE +/-0.49) hours at Week 12 from a baseline of 5.91 (SD +/-1.88) hours for patients taking optimized IR levodopa/carbidopa (LS mean change [SE]). This resulted in a statistically significant improvement of 1.79 (SE +/-0.63) hours in patients on PRODUODOPA vs oral IR LD/CD (LS mean of difference [SE]; P=0.0054).

^†Model-based least square mean (standard error) of change.

^‡Calculated by dividing the change in hours from baseline by the number of hours reported at baseline.

IR=immediate-release; LD/CD=levodopa/carbidopa; LS=least squares; PD=Parkinson's disease; SD=standard deviation; SE=standard error.

A Greater Proportion of Patients Taking PRODUODOPA Awoke Without Morning Akinesia vs Oral IR Levodopa/Carbidopa^1,3

12-Week Study

A Greater Proportion of Patients Taking PRODUODOPA Awoke Without Morning Akinesia vs Oral IR Levodopa/Carbidopa^1,3

12-Week Study

Note to affiliate: Morning akinesia has been included within the Study 736 publication and is being reviewed as part of the "Type II variation SmPC assessment" by MPA. Please assess inclusion of morning akinesia information data based on your local rules and regulations

Percentage of patients waking up in the “On” state*^†‡

Secondary efficacy endpoints were tested in hierarchical order. Hierarchical testing ended after the first secondary endpoint as the next prespecified endpoint did not reach significance.³ PRODUODOPA demonstrated improvements at Week 12 in morning akinesia compared to baseline, but did not achieve statistical significance when compared to active control arm.¹

*Morning akinesia was defined as reporting “Off” status as the first morning symptom upon awakening.

^†Percentage of patients without morning akinesia is the sum of patients reporting “On” time without dyskinesia, “On” time with non-troublesome dyskinesia, and “On” time with troublesome dyskinesia upon awakening.

^‡Based on the PD diary, patients on PRODUODOPA, “On” without dyskinesia was reported in 70% (33/47) of patients; “On” with nontroublesome dyskinesia was reported in 8% (4/47) of patients; “On” with troublesome dyskinesia was reported in 4% (2/47) of patients. For patients on oral IR LD/CD “On” without dyskinesia was reported in 37% (22/60) of patients. Based on the PD diary, 79% (56/71) of patients on PRODUODOPA experienced morning akinesia at baseline and decreased to 17% (8/47) of patients at Week 12. By comparison, 76% (51/67) of patients taking optimized oral IR LD/CD experienced morning akinesia at baseline and decreased to 63% (38/60) of patients at Week 12.

^§Calculated by dividing the change in hours from baseline by the number of hours reported at baseline.

IR=immediate-release; LD/CD=levodopa/carbidopa; PD=Parkinson’s disease.

Study Design
Motor Symptoms

PRODUODOPA 52-Week Safety Study Design^1,2

PRODUODOPA Safety Study Design^1,2

Aim: Evaluate the safety and tolerability of 24-hour daily exposure with a continuous subcutaneous infusion of PRODUODOPA. Secondary efficacy endpoints were also evaluated.

Duration: 52 weeks (this study is ongoing).

Study type: Phase 3, single-arm, open-label.

Patient population: Evaluation of 244 patients. 137 patients completed the 52-week study. The target population was levodopa-responsive patients with PD whose motor symptoms were inadequately controlled with current treatment and experienced a minimum of 2.5 hours of “Off” time per day as assessed by PD diaries.*

PD=Parkinson’s disease.

See Trial Endpoints

Please refer to the PRODUODOPA SmPC for full study data.

See Trial Endpoints

Please refer to the PRODUODOPA SmPC for full study data.

PRODUODOPA subcutaneous administration and DUODOPA^® (levodopa/carbidopa intestinal gel) enteral administration were shown to have comparable levodopa C_max, AUC, and degree of fluctuation, which support a comparable efficacy profile.¹

View DUODOPA Data

AUC=area under the curve; C_max=peak concentration.

Note to affiliate: Click through this button to review levodopa Cmax and AUC parameters for DUODOPA and PRODUODOPA, which support a comparable efficacy profile.

PRODUODOPA subcutaneous administration and DUODOPA^® (levodopa/carbidopa intestinal gel) enteral administration were shown to have comparable levodopa C_max, AUC, and degree of fluctuation, which support a comparable efficacy profile.¹

View DUODOPA Data

AUC=area under the curve; C_max=peak concentration.

Note to affiliate: Click through this button to review levodopa Cmax and AUC parameters for DUODOPA and PRODUODOPA, which support a comparable efficacy profile.

Patients Treated With PRODUODOPA Experienced MORE “On” Time Without Troublesome Dyskinesia^1,2

52-Week Study

Patients Treated With PRODUODOPA Experienced MORE “On” Time Without Troublesome Dyskinesia^1,2

52-Week Study

The PRODUODOPA safety study is ongoing. Data presented reflect the third interim analysis of 52-week study results that include 104 patients. “On” time without troublesome dyskinesia improved by an average of 3.8 (+/-3.3) hours by Week 52 (average 12.9 hours*) compared to baseline (average 9.1 [+/-2.5] hours*; n=236)
(P≤0.001) based on the PD diary.^1,2

*Values represent unadjusted mean hours (+/-standard deviation) assessed using a 24-hour PD diary and normalised to a 16-hour waking day. Only patients who completed each study visit were included in the efficacy analysis, and no adjustments were made to account for premature discontinuation.

^†Calculated by dividing the change in hours from baseline by the number of hours reported at baseline.

Patients Treated With PRODUODOPA Experienced Less “Off” Time^1,2

52-Week Study

Patients Treated With PRODUODOPA Experienced Less “Off” Time^1,2

52-Week Study

The PRODUODOPA safety study is ongoing. Data presented reflect the third interim analysis of 52-week study results that include 104 patients. “Off” time was decreased by an average of 3.5 (+/-3.1) hours by Week 52 (average 2.4 hours) compared to baseline (average 5.9 [+/-2.2] hours*; n=236) (P≤0.001) based on the PD diary.^1,2

^†Calculated by dividing the change in hours from baseline by the number of hours reported at baseline.

Continue to Safety page

Safety

Please refer to the PRODUODOPA SmPC for complete Prescribing and Safety Infomation.

REFERENCES:

[DRAFT] Produodopa^® (foslevodopa/foscarbidopa solution for infusion) Summary of Product Characteristics (SmPC). <insert current SmPC date>.
Aldred J, Freire-Alvarez E, Amelin AV, et al. Continuous Subcutaneous Foslevodopa/Foscarbidopa in Parkinson's Disease: Safety and Efficacy Results From a 12-Month, Single-Arm, Open-Label, Phase 3 Study. Neurol Ther. 2023. doi: 10.1007/s40120-023-00533-1. Epub ahead of print.
Soileau MJ, Aldred J, Budur K, et al. Safety and efficacy of continuous subcutaneous foslevodopa-foscarbidopa in patients with advanced Parkinson's disease: a randomised, double-blind, active-controlled, phase 3 trial. Lancet Neurol. 2022;21(12):1099-1109. doi:10.1016/S1474-4422(22)00400-8. Erratum in: Lancet Neurol. 2023 Mar;22(3):e5.
Rosebraugh M, Liu W, Neenan M, Facheris MF. Foslevodopa/foscarbidopa is well tolerated and maintains stable levodopa and carbidopa exposure following subcutaneous infusion. J Parkinsons Dis. 2021;11(4):1695-1702. doi:10.3233/JPD-212813
Rosebraugh M, Stodtmann S, Liu W, Facheris MF. Foslevodopa/foscarbidopa subcutaneous infusion maintains equivalent levodopa exposure to levodopa-carbidopa intestinal gel delivered to the jejunum. Parkinsonism Relat Disord. 2022;97:68-72.

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

PRODUODOPA^® Indication and Summary of Important Treatment Considerations¹

Indication:

Treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results.

Contraindications:

PRODUODOPA is contraindicated in patients with hypersensitivity to the active substances or to any of the excipients, narrow-angle glaucoma, severe heart failure, acute stroke, severe cardiac arrhythmia, co-medication with selective type A inhibitors and nonselective MAO inhibitors, conditions contraindicated for adrenergics (e.g. pheochromocytoma, hyperthyroidism, and Cushing’s syndrome), and suspicious skin lesions or history of melanoma.

Some special warnings and precautions for PRODUODOPA:

• Not recommended for the treatment of drug-induced extrapyramidal reactions.

• Caution use in patients with: severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease, or history of peptic ulcer disease or of convulsions, history of myocardial infarction with residual atrial nodal or ventricular arrhythmias, cardiac function should be monitored during the initial dosage adjustments. Monitor all patients for the development of mental changes, depression with suicidal tendencies, and other serious mental changes. Caution with past or current psychosis and antipsychotics. Higher frequency of hallucinations may occur with dopamine agonists and/or other dopaminergic treatments including PRODUODOPA. Monitor patients regularly for the development of impulse control disorders, for example Dopamine Dysregulation Syndrome (DDS). Caution in chronic wide-angle glaucoma; monitor for intra-ocular pressure changes. Levodopa may induce hypotension, somonolence and sudden sleep: caution should be exercised when driving and operating machines. Risk of symptoms resembling Neuroleptic Malignant Syndrome following abrupt dose reduction or discontinuation.

• Patients with Parkinson’s disease have a higher risk of developing melanoma. Monitor patients for melanomas on a regular basis when using PRODUODOPA.

• Periodic evaluation of hepatic, haematopoietic, cardiovascular and renal function is recommended during extended therapy with PRODUODOPA.

• PRODUODOPA contains hydrazine (foscarbidopa degradation product), that can be genotoxic and probably carcinogenic. The approximately median exposure of hydrazine is 0.2 mg/day, with a maximum of 0.5 mg/day. The clinical significance of this hydrazine exposure is not known.

• Polyneuropathy has been reported; evaluate for history/signs of and known risk factors before starting therapy.

• PRODUODOPA is high in sodium; considered especially in patients on a low salt diet.

• Caution is needed in concomitant administration of PRODUODOPA with the following medicinal products: Antihypertensive, antidepressants, COMT inhibitors, dopamine agonists, MAO inhibitors, amantadine. Foscarbidopa is a potential inducer of CYP1A2 in vitro. Care should be taken when prescribing PRODUODOPA in combination with sensitive CYP1A2 substrates (e.g. caffeine).

• PRODUODOPA is not recommended during pregnancy. Breast-feeding should be discontinued during treatment with PRODUODOPA.

• The most frequent adverse reactions (≥10%) were infusion site events (infusion site erythema, infusion site nodule, infusion site cellulitis, infusion site oedema, infusion site pain, infusion site infection, and infusion site reaction), hallucination, fall, anxiety, and dizziness.

• Infusion site events were reported with Produodopa in the clinical studies. Following aseptic techniques and frequent rotation of the infusion site are recommended to reduce the risk. Few patients who reported infusion site reactions also experienced infusion site infections. Therefore, careful monitoring of serious infusion site reactions and infusion site infections is recommended.

Please refer to the Produodopa SmPC for complete Prescribing and Safety Information.

ALL-PRODD-220020. Date of preparation: July 2023.

Note to affiliate: This pop-up includes endpoints that may not be included within the SmPC. Please refer to accompanying PRODUODOPA Campaign Guidance Document.

PRODUODOPA 12-Week Efficacy and Safety Study Endpoints³

Primary

• Change from baseline to Week 12 in “On” time without troublesome dyskinesia (hours/day)^a,b

Key Secondary

Change from baseline to Week 12 in:

• “Off” time (hours/day)^b

• Motor aspects of experiences of daily living (MDS-UPDRS)^c

• Morning akinesia (%)^d

Other Secondary

Change from baseline to Week 12 in:

• “On” time without dyskinesia (hours/day)

• Sleep symptoms (PDSS-2)

• Quality of life (PDQ-39)

• Quality of life (EQ-5D-5L)^e

• PD symptoms (median/IQR PKG bradykinesia and dyskinesia score)

Data reported as least squares mean change from baseline (SE), unless otherwise stated. Treatment difference is the difference between least squares mean changes (SE). Morning akinesia reported as least squares mean of odds ratio (SE) at Week 12. Secondary efficacy endpoints were tested in a hierarchical order.

^a“On” time without troublesome dyskinesia is the sum of “On” time without dyskinesia and “On” time with non-troublesome dyskinesia.

^bBased on PD diary (normalized to a 16-hour waking day and averaged over 3 consecutive days).

^cMDS-UPDRS Part II score.

^dMorning akinesia is defined as reporting “Off” status as the first morning symptom on waking.

^eEQ-5D-5L summary index is based on the weighted scoring algorithm for the United States.

EQ-5D-5L=EuroQol 5-Dimension Questionnaire; IQR=InterQuartile Range; MDS-UPDRS=Movement Disorder Society—Unified Parkinson’s Disease Rating Scale; PDSS-2=Parkinson’s Disease Sleep Scale-2; PDQ-39=39-item Parkinson’s Disease Questionnaire; PKG=Parkinson’s KinetiGraph or Personal KinetiGraph (Global Kinetics, MN, USA); SE=standard error.

Note to affiliates: This pop-up includes endpoints that may not be included within the SmPC. Please refer to accompanying PRODUODOPA Campaign Guidance Document. All secondary endpoints included here for completeness and transparency, however, a few of them did not meet statistical significance based on hierarchy. These endpoints appear within the Study 736 publication and are pending assessment within the Type II variation SmPC assessment by MPA. Please assess inclusion based on your local rules and regulations. Only data from SmPC related to "On" and "Off" time can be discussed.

PRODUODOPA 52-Week Safety Study Endpoints²

Primary

• Adverse events (%)^a

• Percentage of patients with adverse events of special interest^a

• Percentage of patients with numeric grade ≥5 and with letter grade ≥D on the Infusion Site Evaluation Scale^b

Change from baseline to end of study in:

• Clinical laboratory test data

• Vital sign measurements

• Electrocardiograms (ECGs)

Secondary

Change from baseline to end of study in:

• Average normalized daily “Off” time and “On” time^c

• Motor aspects of experiences of daily living^d

• Sleep symptoms^e

• Quality of life^f

• Health-related quality of life^g

• Morning akinesia (%)^h

^aFrom initiation of continuous subcutaneous infusion (CSCI) through 30 days after last infusion device was removed (up to 56 weeks).

^bThe Infusion Site Evaluation Scale, a two-part numeric (0-7) and letter (A-G) grade scale, where 7 and G indicated the worst outcomes, was used to assess skin tolerability.⁴

^cPD diary.

^dMovement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Parts I-IV (with Part III measured in the patients' best "On" state) score.

^eParkinson’s Disease Sleep Scale-2 (PDSS-2) total score.

^fPD Questionnaire-39 items (PDQ-39).

^gEuroQol 5-dimensions questionnaire (EQ-5D-5L).

^hPercentage of subjects with early morning “Off” status based on the first morning symptom upon awakening derived from PD diary.

PD=Parkinson’s disease.

Note to affiliate: All secondary endpoints are included here for completeness, however, endpoints aside from "On" and "Off" time are pending Regulatory Agency feedback for inclusion within the draft SmPC filed for Type II variation.

Subcutaneous PRODUODOPA and enteral DUODOPA^® (levodopa/carbidopa intestinal gel) were shown to have comparable levodopa C_max, AUC, and degree of fluctuation, supporting a comparable efficacy profile.¹

Levodopa exposure following 24-hour PRODUODOPA infusion and 16-hour DUODOPA infusion followed by nighttime oral LD/CD doses⁵

Formulation

PRODUODOPA

DUODOPA + Nighttime Oral LD/CD

Note to affiliate: the graph presented here is based on the published Rosebraugh reference, however the colors have been adjusted to match the project. Please update per your local rules and regulations.

DUODOPA^® Provides Less “Off” Time and More “On” Time Without Troublesome Dyskinesia^2,4

DUODOPA demonstrated significant improvements in “Off” time (baseline to endpoint) and “On” time without troublesome dyskinesia (baseline to endpoint) compared to oral levodopa/carbidopa (LS mean difference). Analysis of other secondary efficacy endpoints are not presented here. Please refer to the PRODUODOPA SmPC for further information about these endpoints.

Duration: 12 weeks. Study type: Randomized, double-blind, double-dummy, double-titration trial. Patient population: 71 adult patients with advanced PD and motor complications. Aim: To assess the efficacy and safety of levodopa-carbidopa intestinal gel delivered continuously through an intrajejunal percutaneous tube. Primary endpoint: Change from baseline to final visit in motor “Off” time.⁴

LS=least squares; SD=standard deviation; SE=standard error.

^aActive control, oral levodopa/carbidopa 100/25 mg tablets.

Africa

Asia Pacific

Europe

Middle East

North America

Latin America / Caribbean

South America

PRODUODOPA Clinical Studies

PRODUODOPA Clinical Studies

The efficacy and safety of 24-hour continuous levodopa-based therapy with PRODUODOPA were demonstrated in 2 trials.1-3

12-Week

52-Week

PRODUODOPA 12-Week Efficacy and Safety Study Design1,3

PRODUODOPA 12-Week Efficacy and Safety Study Design1,3

What Does 24-Hour Continuous Delivery Without Surgery Mean for Your Patients?

What Does 24-Hour Continuous Delivery Without Surgery Mean for Your Patients?

Reduction in morning "Off" state (morning akinesia)1*

Fewer interruptions over 24 hours morning, day, and night3*

More “On” time and less “Off” time over 24 hours means patients can do more1†

PRODUODOPA Provided a Superior Improvement in Good “On” Time vs Oral IR Levodopa/Carbidopa1,3

12-Week Study

PRODUODOPA Provided a Superior Improvement in Good “On” Time vs Oral IR Levodopa/Carbidopa1,3

12-Week Study

PRODUODOPA Provided a Superior Improvement in Daily “Off” Time vs Oral IR Levodopa/Carbidopa1,3

12-Week Study

PRODUODOPA Provided a Superior Improvement in Daily “Off” Time vs Oral IR Levodopa/Carbidopa1,3

12-Week Study

A Greater Proportion of Patients Taking PRODUODOPA Awoke Without Morning Akinesia vs Oral IR Levodopa/Carbidopa1,3

12-Week Study

A Greater Proportion of Patients Taking PRODUODOPA Awoke Without Morning Akinesia vs Oral IR Levodopa/Carbidopa1,3

12-Week Study

PRODUODOPA 52-Week Safety Study Design1,2

PRODUODOPA Safety Study Design1,2

PRODUODOPA subcutaneous administration and DUODOPA® (levodopa/carbidopa intestinal gel) enteral administration were shown to have comparable levodopa Cmax, AUC, and degree of fluctuation, which support a comparable efficacy profile.1

PRODUODOPA subcutaneous administration and DUODOPA® (levodopa/carbidopa intestinal gel) enteral administration were shown to have comparable levodopa Cmax, AUC, and degree of fluctuation, which support a comparable efficacy profile.1

Patients Treated With PRODUODOPA Experienced MORE “On” Time Without Troublesome Dyskinesia1,2

52-Week Study

Patients Treated With PRODUODOPA Experienced MORE “On” Time Without Troublesome Dyskinesia1,2

52-Week Study

Patients Treated With PRODUODOPA Experienced Less “Off” Time1,2

52-Week Study

Patients Treated With PRODUODOPA Experienced Less “Off” Time1,2

52-Week Study

Continue to Safety page

PRODUODOPA® Indication and Summary of Important Treatment Considerations1

Indication:

Contraindications:

PRODUODOPA 12-Week Efficacy and Safety Study Endpoints3

PRODUODOPA 12-Week Efficacy and Safety Study Endpoints3

Primary

Key Secondary

Other Secondary

PRODUODOPA 52-Week Safety Study Endpoints2

PRODUODOPA 52-Week Safety Study Endpoints2

Primary

Secondary

Subcutaneous PRODUODOPA and enteral DUODOPA® (levodopa/carbidopa intestinal gel) were shown to have comparable levodopa Cmax, AUC, and degree of fluctuation, supporting a comparable efficacy profile.1

Subcutaneous PRODUODOPA and enteral DUODOPA® (levodopa/carbidopa intestinal gel) were shown to have comparable levodopa Cmax, AUC, and degree of fluctuation, supporting a comparable efficacy profile.1

Levodopa exposure following 24-hour PRODUODOPA infusion and 16-hour DUODOPA infusion followed by nighttime oral LD/CD doses5

Formulation

DUODOPA® Provides Less “Off” Time and More “On” Time Without Troublesome Dyskinesia2,4

DUODOPA® Provides Less “Off” Time and More “On” Time Without Troublesome Dyskinesia2,4

Οι Θεραπευτικές κατηγορίες μας

Our therapy areas

Additional info

Additional info

Αυτή η ιστοσελίδα απευθύνεται σε Έλληνες Επαγγελματίες Υγείας

This website is intended for Italy Healthcare Professionals

The efficacy and safety of 24-hour continuous levodopa-based therapy with PRODUODOPA were demonstrated in 2 trials.^1-3

PRODUODOPA 12-Week Efficacy and Safety Study Design^1,3

PRODUODOPA 12-Week Efficacy and Safety Study Design^1,3

Reduction in morning "Off" state (morning akinesia)¹*

Fewer interruptions over 24 hours morning, day, and night^3*

More “On” time and less “Off” time over 24 hours means patients can do more^1†

PRODUODOPA Provided a Superior Improvement in Good “On” Time vs Oral IR Levodopa/Carbidopa^1,3

PRODUODOPA Provided a Superior Improvement in Good “On” Time vs Oral IR Levodopa/Carbidopa^1,3

PRODUODOPA Provided a Superior Improvement in Daily “Off” Time vs Oral IR Levodopa/Carbidopa^1,3

PRODUODOPA Provided a Superior Improvement in Daily “Off” Time vs Oral IR Levodopa/Carbidopa^1,3

A Greater Proportion of Patients Taking PRODUODOPA Awoke Without Morning Akinesia vs Oral IR Levodopa/Carbidopa^1,3

A Greater Proportion of Patients Taking PRODUODOPA Awoke Without Morning Akinesia vs Oral IR Levodopa/Carbidopa^1,3

PRODUODOPA 52-Week Safety Study Design^1,2

PRODUODOPA Safety Study Design^1,2

PRODUODOPA subcutaneous administration and DUODOPA^® (levodopa/carbidopa intestinal gel) enteral administration were shown to have comparable levodopa C_max, AUC, and degree of fluctuation, which support a comparable efficacy profile.¹

PRODUODOPA subcutaneous administration and DUODOPA^® (levodopa/carbidopa intestinal gel) enteral administration were shown to have comparable levodopa C_max, AUC, and degree of fluctuation, which support a comparable efficacy profile.¹

Patients Treated With PRODUODOPA Experienced MORE “On” Time Without Troublesome Dyskinesia^1,2

Patients Treated With PRODUODOPA Experienced MORE “On” Time Without Troublesome Dyskinesia^1,2

Patients Treated With PRODUODOPA Experienced Less “Off” Time^1,2

Patients Treated With PRODUODOPA Experienced Less “Off” Time^1,2

PRODUODOPA^® Indication and Summary of Important Treatment Considerations¹

PRODUODOPA 12-Week Efficacy and Safety Study Endpoints³

PRODUODOPA 12-Week Efficacy and Safety Study Endpoints³

PRODUODOPA 52-Week Safety Study Endpoints²

PRODUODOPA 52-Week Safety Study Endpoints²

Subcutaneous PRODUODOPA and enteral DUODOPA^® (levodopa/carbidopa intestinal gel) were shown to have comparable levodopa C_max, AUC, and degree of fluctuation, supporting a comparable efficacy profile.¹

Subcutaneous PRODUODOPA and enteral DUODOPA^® (levodopa/carbidopa intestinal gel) were shown to have comparable levodopa C_max, AUC, and degree of fluctuation, supporting a comparable efficacy profile.¹

Levodopa exposure following 24-hour PRODUODOPA infusion and 16-hour DUODOPA infusion followed by nighttime oral LD/CD doses⁵

DUODOPA^® Provides Less “Off” Time and More “On” Time Without Troublesome Dyskinesia^2,4

DUODOPA^® Provides Less “Off” Time and More “On” Time Without Troublesome Dyskinesia^2,4