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Phase 1: Driving Simulation Study

Crossover Design - 3 Days for 3 Weeks (n=35)

OMZYA® 150 mg (TID)
vs Placebovs Cyclobenzaprine 10 mg (TID)
vs Cyclobenzaprine 10 mg (TID)  
Primary Endpoint: Standard deviation of lateral position (SDLP) – measure of an individual’s ability to maintain lane position
Secondary Endpoints: Measures of sleepiness (KSS)
DAY 3
DAY 1
Bedtime
Bedtime
Dose
DAY 2
1
3
Dose
1
3
2
2
1
Sleepiness Assessment –
Driving Simulation –
Sleepiness Assessment –
Driving Simulation –
Sleepiness Assessment –
Driving Simulation –

OMZYA® Outperformed Cyclobenzaprine on Sleepiness and Driving Performance

Sleepiness

P=<0.0001
P=<0.00001
DAY 1
DAY 3
OMZYA® similar to placebo across all study days
DAY 2
9
8
7
6
5
4
3
2
1

As assessed by the Karolinska Sleepiness Scale (KSS) which uses a scale of 1 to 9, where 1 equals extremely alert and 9 equals extremely sleepy/fighting sleep

Standard Deviation of Lateral Position (SDLP)

Individual’s Ability to Maintain Lane Position (Weaving)
9.5
8.5
7.5
6.5
5.5
4.5
3.5
2.5
1.5
0.5
-0.5
OMZYA® similar to placebo across all study days
DAY 1
DAY 2
DAY 3
P=0.001
P=0.0001
P=0.008

OMZYA® Outperformed Cyclobenzaprine on Sleepiness and Driving Performance

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