INFORMATION TO FOLLOW
ACUTE MUSCLE SPASM
COMPLETED
COMPLETED
COMPLETED
PLANNED FOR 2022
Driving Simulation
CNS Effects & Driving Simulation
RESUME-2: Safety & Efficacy
Post-Stroke Spacticity (PSS)
Neuropathic Pain (NP)
RESUME-1: Safety & Efficacy
STAR: Dose Ranging
PHASE I
PHASE II
PHASE III
INFORMATION TO FOLLOW
STUDY
NP
PSS
Efficient and Robust Clinical Development
Healthy Volunteers
35
Healthy Volunteers
39
3-way crossover (OMZYA® 150 mg, Cyclobenzaprine 10 mg vs Placebo)
4-way crossover (OMZYA® 200 mg, 400 mg, Cyclobenzaprine 10 mg vs Placebo)
Assess safety, driving performance and cognitive effects
Replicate study to support label claims
SDLP; Sleepiness (KSS)
SDLP; Sleepiness (KSS, ESS); Cognitive measures
DEMONSTRATED
Non-drowsiness
(subjective: patient reported)
Low CNS effect
(objective: driving performance)
PHASE I
Driving Study
CNS Effects Study
STUDY TYPE
(type)
(n)
SUBJECTS
PURPOSE
MEASURES
KEY RESULTS
Accute Muscle Spasm Clinical Study Overview
Adult Subjects
Aged 18-64
TBD
Double-blind, randomized safety and efficacy (OMZYA® doses TBD pending RESUME-1)
ONGOING
PLANNED 2022
Double-blind, randomized safety and efficacy (OMZYA® 50 mg, 100 mg, 200 mg vs Placebo)
1000
Adult Subjects
Aged 18-64
Patient reported pain (NRS); Sleepiness (ESS, VAS)
Safety and efficacy
Safety and efficacy
Patient reported pain (NRS); Sleepiness (ESS, VAS)
PHASE III
RESUME-1
RESUME-2
STUDY TYPE
(type)
(n)
PATIENT
PURPOSE
MEASURES
KEY RESULTS
Numerical Rating Scale (NRS). Standard Deviation of Lateral Position (SDLP). Karolinska Sleepiness Scale (KSS). Epsworth Sleepiness Scale (ESS). Visual Analog Scale (VSS)
DEMONSTRATED
Efficacy vs. placebo
Recommended Phase 3 dose
Patient reported pain (NRS); Sleepiness (VAS)
Safety and efficacy study to select dose(s) for Phase 3
Double-blind, randomized dose ranging (OMZYA® 50 mg, 100 mg, 150 mg, 200 mg vs Placebo)
Adult Subjects
Aged 18-64
415
PHASE II
STAR Study
STUDY TYPE
(type)
(n)
PATIENT
PURPOSE
MEASURES
KEY RESULTS
NRS CHANGE FROM BASELINE (ITT)
Baseline
2
4
6
8
10
12
14
OMZYA® 150 mg
OMZYA® 100 mg
OMZYA® 50 mg
Placebo
OMZYA® 200 mg
0
-0.5
-1.0
-1.5
-2.0
-2.5
-3.0
-3.5
-4.0
-4.5
DAYS