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Phase 1: Driving Simulation Study 

Crossover Design -

3 Days for 3 Weeks (n=36)

OMZYA® 150 mg (TID)

vs Placebo

vs Cyclobenzaprine 10 mg (TID)  

Bedtime

8 am

1

Dose

2

3

2 pm

10 pm

DAY 1

Bedtime

8 am

1

Dose

2

3

2 pm

10 pm

8 am

1

DAY 2

DAY 3

 

Sleepiness Assessments   

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Driving Simulation   

 

Sleepiness Assessments   

>

Driving Simulation   

 

Sleepiness Assessments   

>

Driving Simulation   

Primary Endpoint: Standard deviation of lateral position (SDLP) – measure of an individual’s ability to maintain lane position

Secondary Endpoints: Measures of sleepiness (KSS) 
 

SLEEPINESS: OMZYA® SIMILAR TO PLACEBO

Karolinska Sleepiness Scale (KSS)

4

5

6

7

8

9

2

3

1

DAY 1

P=<0.0001

OMZYA® similar to placebo across all study days

DAY 2

DAY 3

P=0.2477

P=0.069

8.5

DAY 1

p=0.001

9.5

8.5

7.5

6.5

5.5

4.5

3.5

2.5

1.5

0.5

-0.5

Increased crash risk with cyclobenzaprine consistent with
blood alcohol concentration (BAC) of 0.05%

DAY 2

p=0.0001

DAY 3

p=0.008

DRIVING: OMZYA® OUTPERFORMS CYCLOBENZAPRINE

Standard Deviation of Lateral Position (SDLP)

OMZYA® Outperformed Cyclobenzaprine on Sleepiness and Driving Performance

Cyclobenzaprine 10 mg

OMZYA® 150 mg

Placebo