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

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

Follow-up

RANDOMIZATION

DAYS

SUBJECTS:

#: 415

Age: 18 to 64 years

RANDOMIZATION:

1:1:1:1:1

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

Enrollment Criteria:

SCREENING & ENROLLMENT:

(-3 to 0 Days)

Phase 2: STAR Study

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

14

4

21

1

150 mg TID (450 mg/day)

50 mg TID (150 mg/day)

100 mg TID (300 mg/day)

200 mg TID (600 mg/day)

Placebo TID

Secondary Endpoint:

Measures of sleepiness (VAS)

Primary Endpoint:

Subject-rated Pain

(NRS) on Day 14

0 = No Pain, 10 = Worst Possible Pain

Overall Number of Subjects with Events

11 (14.1)

10 (12.2)

16 (18.4)

15 (18.1)

20 (23.5)

Headache

3 (3.8)

3 (3.7)

5 (5.7)

8 (9.6)

8 (9.4)

Diarrhea

0 (0.0)

2 (2.4)

0 (0.0)

3 (3.6)

1 (1.2)

Nausea

0 (0.0)

1 (1.2)

1 (1.1)

1 (1.2)

2 (2.4)

Dizziness

0 (0.0)

1 (1.2)

2 (2.3)

0 (0.0)

2 (2.4)

Somnolence

2 (2.6)

0 (0.0)

3 (3.4)

0 (0.0)

1 (1.2)

Vertigo

0 (0.0)

1 (1.2)

0 (0.0)

1 (1.2)

1 (1.2)

Disturbance in Attention

0 (0.0)

0 (0.0)

1 (1.1)

1 (1.2)

0 (0.0)

Dyspepsia

0 (0.0)

0 (0.0)

1 (1.1)

0 (0.0)

1 (1.2)

Vomiting

0 (0.0)

0 (0.0)

0 (0.0)

1 (1.2)

1 (1.2)

Head Discomfort

0 (0.0)

0 (0.0)

1 (1.1)

0 (0.0)

1 (1.2)

Urinary Tract Infection

1 (1.3)

0 (0.0)

0 (0.0)

0 (0.0)

1 (1.2)

Migraine

2 (2.6)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

Low rates of adverse effects;

somnolence similar to placebo

All adverse events with >1 subject reporting an adverse event

1

ADVERSE EVENTS - Patient Reported

N (%)

200 mg

(N=85)

150 mg

(N=83)

50 mg

(N=82)

100 mg

(N=87)

Placebo

(N=78)

1

2

3

4

5

6

7

8

9

10

Placebo

50 mg

100 mg

150 mg

200 mg

0

10 = Very sleepy, difficult remaining awake

0 = Alert, wide awake

Day 4 sleepiness: OMZYA® comparable to placebo across all doses

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

SLEEPINESS - Patient Reported

VAS: Sleepiness Scale

Somnolence and Sleepiness: OMZYA® Similar to Placebo

Subject Rated Pain (NRS): Primary Endpoint

NRS CHANGE FROM BASELINE (ITT)

NRS CHANGE FROM BASELINE (ITT)