Now Approved

Now they can more*

*In the phase 3 clinical trial, patients in the VYALEV group (n=73) experienced a 2.72-hour increase in “On” time without troublesome dyskinesia (sum of “On” time without any dyskinesia and with non-troublesome dyskinesia, as assessed using a PD diary) from baseline to week 12 vs a 0.97-hour increase in patients taking oral IR CD/LD (n=67) (P=0.0083). “On” time was normalized to a daily 16-hour awake period and averaged over valid PD diary days for each visit to obtain the average daily normalized times.1

ONLY SUBCUTANEOUS LEVODOPA-BASED THERAPY

that replaces all oral levodopa and COMT inhibitors1†

SUPERIOR
"ON" TIME VS ORALS

without troublesome
dyskinesia1*

24-HOUR
CONTINUOUS DELIVERY

morning, day, and night1

VYALEV™ Pump.

The maximum recommended daily dosage of VYALEV is 3525 mg of the foslevodopa component (equivalent to approximately 2500 mg levodopa). 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

Superior improvement in
DAILY GOOD “ON” TIME
from baseline to week 12 vs oral IR CD/LD1‡§

~3x

increase in daily
good “On” time
vs oral IR CD/LD1‡§

Primary endpoint:
Mean change from baseline to week 12 in total daily mean
“On” time without troublesome dyskinesia||¶

VYALEV

+  hours

Baseline: 9.20 hours (n=73)

Oral IR CD/LD

+ hours

Baseline: 9.49 hours (n=67)

Mean difference=1.75 hours; P=0.0083

Study Design: A phase 3, randomized, double-blind, active-controlled study to evaluate the efficacy and safety of VYALEV vs oral IR CD/LD over 12 weeks in 141 patients with advanced PD. One VYALEV patient was not evaluable for the efficacy analysis.
See full study design.

Good “On” time (“On” time without troublesome dyskinesia) was defined as the sum of “On” time without dyskinesia and “On” time with non-troublesome dyskinesia and was assessed using a PD diary.1

§2.80x increase.1

|| “On” time was normalized to a daily 16-hour awake period. Daily normalized "On" times are averaged over valid PD diary days for each visit to obtain the average daily normalized times.1

Data based on least squares mean.1

See which of your patients can benefit from VYALEV

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