Phase 1: CNS Effects Study

4-way Crossover Study (n=39)

OMZYA® 200 mg (TID)
vs OMZYA® 400 mg supratherapeutic dose (TID)  
vs Placebo 
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, ESS); Measures of cognitive function (Reaction Time, Rapid Visual Information Processing, and Symbol Digit Coding Test)
DAY 3
DAY 1
Bedtime
Bedtime
Dose
DAY 2
1
3
Dose
Dose
1
3
2
2
1
Cognitive –
Function
– Sleepiness
Assessment
– Driving
Simulation
Sleepiness –
Assessment
Driving –
Simulation
– Cognitive
Function
Cognitive –
Function
– Sleepiness
Assessment
– Driving
Simulation

Somnolence and Sleepiness:
Cyclobenzaprine Demonstrated CNS Effects

Somnolence and Sleepiness:

Cyclobenzaprine Demonstrated CNS Effects

Mean
(%) (SD)

Placebo
(N=36)

OMZYA®
200 mg
(N=36)

OMZYA®
400 mg
(N=36)

Adverse Events - Patient Reported

Cycloben-zaprine
10 mg
(N=36)

n (%)
n (%)
n (%)
Preferred Term
12 (33.3)
6 (15.8)
2 (5.6)
n (%)
7 (19.4)
9 (25.0)
Any TEAE
Somnolence
2 (5.3)
Fatigue
0 (0.0)
1 (2.8)
0 (0.0)
Arthralgia
Nausea
2 (5.6)
15 (13.2)
Diarrhea
Pyrexia
1 (2.8)
0 (0.0)
0 (0.0)
Back Pain
0 (0.0)
Lethargy
0 (0.0)
Headache
Paresthesia
1 (2.8)
0 (0.0)
1 (2.8)
0 (0.0)
Oropharyngeal Pain
1 (2.8)
1 (2.8)
0 (0.0)
0 (0.0)
1 (2.8)
0 (0.0)
1 (2.8)
0 (0.0)
1 (2.8)
0 (0.0)
0 (0.0)
1 (2.8)
1 (2.8)
0 (0.0)
0 (0.0)
1 (2.8)
0 (0.0)
1 (2.8)
0 (0.0)
0 (0.0)
0 (0.0)
0 (0.0)
0 (0.0)
OMZYA® no different than placebo on rates of somnolence; increased somnolence observed with cyclobenzaprine
0 (0.0)
0 (0.0)
0 (0.0)
0 (0.0)
0 (0.0)
All adverse events with >1 subject reporting an adverse event

Daytime Sleepiness- Patient Reported

p=0.0081
p=0.0199
Cyclobenzaprine had higher daytime sleepiness than OMZYA® and placebo
As assessed by the Epworth Sleepiness Scale (ESS) on Day 3
Placebo
4
3.5
3
2.5
2
1.5
1
OMZYA®
200 mg
OMZYA®
400 mg
Cycloben-zaprine
10 mg
Cyclobenzaprine
10 mg
Placebo
OMZYA® 200 mg
OMZYA® 400 mg
Cyclobenzaprine 10 mg

OMZYA®Did Not Affect Driving Performance

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