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PROVEN RESULTS:

Reliable, Robust, and Rapid

Consistent, Reliable ON1:

95%

In clinical trials, 95% of OFF episodes successfully reversed (primary endpoint).1*

97%

97% of first daily dose OFF episodes reversed (secondary endpoint).1

95%

95% of last daily dose OFF episodes reversed (secondary endpoint).1

*Compared to 23% for placebo; P<0.001.1

Study design: A randomized, double-blind, placebo-controlled trial in 29 patients with advanced PD for Parkinsonian OFF-state events. Patients were randomized to receive titrated doses of APOKYN or matched placebo. Primary efficacy endpoint was the change in Unified Parkinson’s Disease Rating Scale (UPDRS) motor score 20 minutes post-injection in the inpatient phase. In the outpatient phase, % of injections aborting OFF-state events was the primary efficacy endpoint. Secondary efficacy endpoints included change in UPDRS motor scores at 10 and 90 minutes and change in Webster Step-Seconds Test (WSST) score.1,3*

ROBUST

Substantial improvements seen in UPDRS III scores.2

19.9 Points

at 10 minutes (secondary endpoint)

24.2 Points

at 20 minutes (primary endpoint)

APOKYN: Rapid, Full ON

7.5 MINUTES2

Significant improvements seen using WSST* (secondary endpoint)2

10 MINUTES2

Significantly improved motor function in UPDRS III scores (secondary endpoint)2

20 MINUTES

90% of patients achieved a best oral levodopa-like ON (primary endpoint)2

Study design: A prospective, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in 62 patients with advanced PD who experienced OFF episodes despite optimal oral therapy. Patients used APOKYN as acute, intermittent therapy for 14.5 months on average before the study. Patients were randomized to receive a single dose of APOKYN or placebo at the typically effective dose, or 0.2 mL higher than that dose, in response to an OFF episode that occurred more than 1 hour after a typical morning dose of oral PD therapy. Mean dose for the APOKYN-treated group was 0.42 mL.2,3

*The onset of APOKYN action was assessed using the WSST, modified to allow completion of each assessment within 60 seconds. The patient began in a sitting position and was asked to stand, walk, turn around, walk back, and sit. The number of steps taken with the right foot per round trip of 15 feet out plus 15 feet back, and the time taken to accomplish the task, were recorded. The test was modified to allow a total evaluation time of 60 seconds.2