Identifying Patients for Therapy

Over 25,000 patients have been prescribed VYALEV globally2*

VYALEV may be appropriate for your active† patients who are:

Burdened with managing oral levodopa ≥4 times daily

Experiencing poorly controlled motor fluctuations that limit their function

Troubled by motor fluctuations throughout the night (ie, feeling frozen) and waking up "Off"

*Number includes total prescriptions written; patient may not have started therapy. Number does not include discontinuations. Product trade name and indication differ by country.

†In the pivotal study (N=141), 62% of patients were Hoehn & Yahr stage 2 and 24% were stage 3. Patients in all stages were enrolled in the study.3

A real patient potting flowers.

VYALEV Patient Stories:
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Hear Janice discuss her experience with VYALEV.

86% of patients enrolled in the VYALEV study were between Hoehn & Yahr stages 2 and 3

The Hoehn & Yahr scale describes the stages of Parkinson’s disease progression3,4‡§

The Hoehn & Yahr scale.

Stage 0

No signs of disease

Stage 1

Unilateral involvement with only minimal or no functional impairment

Stage 2

Bilateral or midline involvement without impairment of balance

Stage 3

First signs of impaired righting reflexes

Stage 4

Severe disability; still able to walk or stand unassisted

Stage 5

Confinement to bed or wheelchair unless assisted

‡Hoehn & Yahr stage was measured in the “On” state.

§While 86% of patients were in Hoehn & Yahr stages 2 or 3, patients in all stages were enrolled in the study.3

In the pivotal study, oral IR CD/LD was converted to VYALEV, so

VYALEV replaced all scheduled oral IR CD/LD1,3,5

On average, patients in the VYALEV group were taking 12 IR CD/LD pills per day at baseline|| and 0 IR CD/LD pills per day at 12-week study end

Average number of IR CD/LD pills per month (30 days)

During a 30 day average, VYALEV® patients were taking 360 IR CD/LD pills per month at baseline and 0 IR CD/LD pills per month at 12-week study end.

Note: Additional doses of rescue IR CD/LD may be needed if the VYALEV Pump is not working or is disconnected for a prolonged period. Refer to the VYALEV Pump Instructions for Use for more information.**

Study Design: A post hoc analysis of the phase 3 clinical trial evaluated the mean daily levodopa dose at both baseline and week 12 in patients (n=74) treated with VYALEV. All levodopa-containing medications and COMT inhibitors were converted to IR levodopa-equivalent doses, and tablet counts were estimated using 100 mg levodopa/25 mg carbidopa tablets. Concomitant PD medications were allowed if kept stable throughout the study. Oral IR CD/LD could be used as needed for rescue.

Limitations: This post hoc analysis was not powered to assess changes in IR CD/LD tablet count from baseline to week 12. High-rate and extra doses were disabled to maintain blinding and were not included in this analysis. Findings should be interpreted with caution.

||Mean daily dose of oral levodopa at baseline was 1202.7 mg.

Mean daily dose of levodopa from all sources at week 12 was 1793.3 mg (levodopa delivered through the pump as VYALEV: 1703.7 mg; levodopa taken orally: 89.6 mg).

#For illustrative purposes. Exact dosage as well as dose frequency and timing varied among patients in the pivotal study.

**The maximum recommended daily dosage of VYALEV is 3525 mg of the foslevodopa component (equivalent to approximately 2500 mg levodopa). In the clinical trial, all dosages of levodopa-containing medications and COMT inhibitors were converted to VYALEV. Prescribing a backup oral carbidopa and levodopa product is recommended in the event that delivery of VYALEV is interrupted, which may result in underdosing.1,3

Explore dosing features of the VYALEV Pump.

Explore dosing

CD=carbidopa; COMT=catechol-O-methyltransferase; IR=immediate release; LD=levodopa; PD=Parkinson's disease.