Two, Replicate Phase 3 Acute Muscle Spasm Studies

750 patients in each study (n=1,500)

1:1:1 Randomization

18 - 64 years

Primary Endpoint Day 14

Numerical Rating Scale (NRS) Pain "right now" primary endpoint

Study to initiate in 2H 2020

Topline data 2H 2021

RANDOMIZATION

100 mg TID (300 mg/day)

200 mg TID (600 mg/day)

Placebo TID

Subject-rated Pain

(NRS)

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

Daily ePRO Assessments and Dosing Diary

Screening & Enrollment

(-3 to 0 Days)

1

4

14

21

Follow-up

DAY