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Placebo

(N=36)

Mean (%) (SD)

Preferred Term

11 (14.1)

10 (12.2)

16 (18.4)

15 (18.1)

Any TEAE

3 (3.8)

3 (3.7)

5 (5.7)

8 (9.6)

Somnolence

0 (0.0)

2 (2.4)

2 (2.3)

3 (3.6)

Headache

0 (0.0)

1 (1.2)

1 (1.1)

1 (1.2)

Fatigue

0 (0.0)

1 (1.2)

2 (2.3)

0 (0.0)

Arthralgia

2 (2.6)

0 (0.0)

3 (3.4)

0 (0.0)

Nausea

0 (0.0)

1 (1.2)

1 (1.2)

1 (1.2)

Diarrhea

0 (0.0)

0 (0.0)

1 (1.1)

1 (1.2)

Pyrexia

0 (0.0)

0 (0.0)

1 (1.1)

0 (0.0)

Back Pain

0 (0.0)

0 (0.0)

0 (0.0)

1 (1.2)

Lethargy

0 (0.0)

0 (0.0)

1 (1.1)

0 (0.0)

Paresthesia

1 (1.3)

0 (0.0)

0 (0.0)

0 (0.0)

Oropharyngeal Pain

2 (2.6)

0 (0.0)

0 (0.0)

0 (0.0)

OMZYA® no different than placebo on rates of somnolence; increased somnolence observed with cyclobenzaprine

All adverse events with >1 subject reporting an adverse event

Blood Pressure Fluctuation

2 (2.6)

0 (0.0)

0 (0.0)

0 (0.0)

OMZYA®

200 mg

(N=36)

OMZYA®

400 mg

(N=38)

Cycloben-zaprine

10 mg

(N=83)

ADVERSE EVENTS - Patient Reported

p=0.0081

p=0.0199

Placebo

OMZYA®

200 mg

OMZYA®

400 mg

Cyclobenzaprine

10 mg

4

3.5

3

2.5

2

1.5

1

Cyclobenzaprine had higher daytime sleepiness than OMZYA® and placebo

As assessed by the Epworth Sleepiness Scale (ESS) on Day 3

DAYTIME SLEEPINESS - Patient Reported

Somnolence and Sleepiness:
Cyclobenzaprine Demonstrated CNS Effects

Cyclobenzaprine 10 mg

OMZYA® 400 mg

OMZYA® 200 mg

Placebo

STANDARD DEVIATION OF LATERAL POSITION (SDLP)

Individual’s Ability to Maintain Lane Position (Weaving)

OMZYA® Did Not Affect Driving Performance

The 200mg finding was due to a single outlier. This subject had no impairment on Day 1 and Day 3 and/or at 400mg

DAY 1

31

30

29

28

27

26

25

DAY 2

DAY 3

OMZYA® demonstrated non-inferiority compared to placebo

Cyclobenzaprine exceeded pre-established non-inferiority margin on all three days

DAY 1

3.0

2.5

2.0

1.5

1.0

0.5

0

DAY 2

DAY 3

Cyclobenzaprine significantly exceeded lanes on all three days

Cyclobenzaprine 10 mg

OMZYA® 400 mg

OMZYA® 200 mg

Placebo

LANE EXCEEDANCE

Number of Times Exceeded Lane

Phase 1: CNS Effects Driving Simulation Study 

Four-way Crossover Study (n=39)

OMZYA® 200 mg (TID)

vs OMZYA® 400 mg supratherapeutic dose (TID)

vs Placebo

vs Cyclobenzaprine 10 mg (TID)

Secondary Endpoints: Measures of sleepiness (KSS, ESS); Measures of cognitive function (Reaction Time, Rapid Visual Information Processing and Symbol Digit Coding Test)

Primary Endpoint: Standard deviation of lateral position

(SDLP) – measure of an individual’s ability to maintain lane position

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   

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Driving Simulation   

 

Sleepiness Assessments   

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Driving Simulation   

 

Cognitive Function

 

Cognitive Function

 

Cognitive Function