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POTENTIAL FUTURE INDICATIONS 

POTENTIAL FUTURE INDICATIONS 

ACUTE MUSCLE SPASM

COMPLETED

COMPLETED

COMPLETED

ONGOING

ONGOING

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 1

PHASE 2

PHASE 3

STUDY

NP

PSS

Efficient and Robust Clinical Development 

Acute Muscle Spasm Clinical Studies Overview

Efficient and Robust Clinical Development 

COMPLETED

(initiates Q1 2022)

(topline data Q4 2021)

ACUTE MUSCLE SPASM

PHASE 3

ONGOING/PLANNED

Neuropathic Pain (NP)

Post-Stroke Spasticity (PSS)

PSS

NP

ADDITIONAL INDICATIONS

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

PHASE 1

Driving Study

CNS Effects Study

STUDY TYPE

(type)

(n)

SUBJECTS
PURPOSE
MEASURES
KEY RESULTS

Healthy Volunteers

35

3-way crossover (OMZYA® 150 mg, Cyclobenzaprine 10 mg vs Placebo)

Assess safety, driving performance and cognitive effects

SDLP; Sleepiness (KSS)

DEMONSTRATED


Non-drowsiness

(subjective: patient reported)


Low CNS effect

(objective: driving performance)

Double-blind, randomized dose ranging (OMZYA® 50 mg, 100 mg, 150 mg, 200 mg vs Placebo)

Patient reported pain (NRS); Sleepiness (VAS)

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

Adult Subjects

Aged 18-64

415

PHASE  2

STAR Study

STUDY TYPE

(type)

(n)

SUBJECTS
PURPOSE
MEASURES
KEY RESULTS

DEMONSTRATED

Pain reduction and was generally well tolerated

Recommended Phase 3 dose

Adult Subjects

Aged 18-64

TBD

Double-blind, randomized safety and efficacy (OMZYA® doses TBD pending RESUME-1)

Patient reported pain (NRS);  Sleepiness (ESS, VAS)

Safety and efficacy

PHASE 3

RESUME-1

RESUME-2

STUDY TYPE

(type)

(n)

SUBJECT
PURPOSE
MEASURES
KEY RESULTS

Double-blind, randomized safety and efficacy (OMZYA® 50 mg, 100 mg, 200 mg vs Placebo)

1000

Adult Subjects

Aged 18-64

Safety and efficacy

Patient reported pain (NRS);  Sleepiness (ESS, VAS)

ONGOING

PLANNED 2022