Phase 2: STAR Study

Safety and efficacy study to select dose(s) for Phase 3

DAY

ENROLLMENT

Enrollment Criteria

Current acute back pain and/or stiffness due to acute and painful muscle spasms

Numerical Rating Scale (NRS) pain of 4 or more at baseline

SUBJECTS:

#: 415
Age: 18 to 64 years

RANDOMIZATION:

1:1:1:1:1

SCREENING & ENROLLMENT:

(-3 to 0 Days)

OMZYA® 50 mg TID (150 mg/day)

OMZYA® 150 mg TID (450 mg/day)

OMZYA® 100 mg TID (300 mg/day)

OMZYA® 200 mg TID (600 mg/day)

Placebo TID

Subject-Rated Pain Numerical Rating Scale (NRS) on Day 1, 4, 14

Daily electronic patient-reported (ePRO) Assessments and Dosing Diary

Primary Endpoint:

Subject-rated Pain

(NRS) on Day 14

0 = No Pain,
10 = Worst Possible Pain

Secondary Endpoint:

Measures of sleepiness (VAS)

Follow-up

Somnolence and Sleepiness:

OMZYA® Similar to Placebo

N (%)

Placebo
(N=78)

OMZYA®
50 mg
(N=82)

OMZYA®
100 mg
(N=87)

Adverse Events- Patient Reported

OMZYA®
150 mg
(N=83)

16 (18.4)

OMZYA®
200 mg
(N=85)

11 (14.1)

Overall # of Subjects

20 (23.5)

8 (9.6)

5 (5.7)

3 (3.7)

10 (12.2)

3 (3.8)

8 (9.4)

3 (3.6)

15 (18.1)

Headache

Diarrhea

0 (0.0)

1 (1.2)

Dizziness

1 (1.2)

0 (0.0)

2 (2.4)

Somnolence

2 (2.4)

Vertigo

0 (0.0)

1 (1.1)

Disturbance in Attention

Dyspepsia

2 (2.4)

0 (0.0)

1 (1.2)

Vomiting

0 (0.0)

1 (1.2)

Head Discomfort

1 (1.2)

Nausea

Urinary Tract Infection

0 (0.0)

1 (1.2)

3 (3.4)

Migraine

1 (2.6)

0 (0.0)

1 (1.2)

0 (0.0)

1 (1.2)

0 (0.0)

1 (1.3)

1 (1.2)

2 (2.6)

0 (0.0)

1 (1.1)

0 (0.0)

1 (1.2)

0 (0.0)

1 (1.1)

1 (1.2)

0 (0.0)

Low rates of adverse effects;somnolence similar to placebo

0 (0.0)

All adverse events with >1 subject reporting an adverse event

Sleepiness- Patient Reported

Cyclobenzaprine had higher daytime sleepiness than OMZYA® and placebo

As assessed by the Visual Analogue Scale (VAS) for sleepiness on a scale of 0 to 10, where 0=alert, wide awake to 10=very sleepy, difficulty remaining awake

Placebo

50 mg

100 mg

150 mg

200 mg

Phase 2: STAR Study

Enrollment Criteria

SUBJECTS:

RANDOMIZATION:

SCREENING & ENROLLMENT:

Primary Endpoint:

Secondary Endpoint:

Follow-up

Somnolence and Sleepiness:

OMZYA® Similar to Placebo

N (%)

Placebo
(N=78)

OMZYA®
50 mg
(N=82)

OMZYA®
100 mg
(N=87)

Adverse Events- Patient Reported

OMZYA®
150 mg
(N=83)

OMZYA®
200 mg
(N=85)

Sleepiness- Patient Reported

Somnolence and Sleepiness: OMZYA® Similar to Placebo

Subject Rated Pain (NRS): Primary Endpoint

Phase 2: STAR Study

Enrollment Criteria

SUBJECTS:

RANDOMIZATION:

SCREENING & ENROLLMENT:

Primary Endpoint:

Secondary Endpoint:

Follow-up

Somnolence and Sleepiness:

OMZYA® Similar to Placebo

N (%)

Placebo(N=78)

OMZYA®50 mg(N=82)

OMZYA®100 mg(N=87)

Adverse Events- Patient Reported

OMZYA®150 mg(N=83)

OMZYA®200 mg(N=85)

Sleepiness- Patient Reported

Somnolence and Sleepiness: OMZYA® Similar to Placebo

Subject Rated Pain (NRS): Primary Endpoint

Placebo
(N=78)

OMZYA®
50 mg
(N=82)

OMZYA®
100 mg
(N=87)

OMZYA®
150 mg
(N=83)

OMZYA®
200 mg
(N=85)