phase 1
CNS Effects Study
Driving Simulation
subjects
study type
purpose
Measures
(type)
(n)
subjects
study type
purpose
Measures
(type)
(n)
subjects
study type
purpose
Measures
(type)
(n)
key results
key results
key results
Adult Patients Aged 18-64
415
Double-blind, randomized dose ranging (OMZYA® 50 mg, 100 mg, 150 mg, 200 mg vs Placebo)
Safety and efficacy study to select dose(s) for Phase 3
Patient reported pain (NRS); Sleepiness (VAS)
Healthy Volunteers
35
4-way crossover (OMZYA® 200 mg, 400 mg, Cyclobenzaprine 10 mg vs Placebo
Replicate study to support label claims
SDLP; Sleepiness
(KSS, ESS); Cognitive measures
Healthy Volunteers
35
3-way crossover (OMZYA® 150 mg, Cyclobenzaprine 10 mg vs Placebo)
Assess safety, driving performance and cognitive effects
SDLP; Sleepiness (KSS)
Non-drowsiness
(subjective: patient reported)
Low CNS effect
(objective: driving performance)
Pain reduction and was generally well tolerated
Recommended Phase 3 dose
Adult Patients Aged 18-64
1000
Double-blind, randomized safety and efficacy (OMZYA® 50 mg, 100 mg, 200 mg vs Placebo)
Safety and efficacy
Patient reported pain (NRS); Sleepiness (ESS, VAS)
Adult Patients Aged 18-64
TBD
Double-blind, randomized safety and efficacy (OMZYA® doses TBD pending RESUME-1)
Safety and efficacy
Patient reported pain (NRS); Sleepiness (ESS, VAS)
