Phase 2: STAR Study

415 patients

18 - 65 years

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

Numerical Rating Scale

(NRS) pain of 4 or more at baseline 

Follow-up

Daily ePRO Pain Assessments through Day 14

RANDOMIZATION

Screening & Enrollment

Subject-rated Pain

(NRS)

100 mg TID

50 mg TID 

150 mg TID

Placebo

200 mg TID

1

4

14

21

DAY