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INFORMATION TO FOLLOW

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 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

Subject Rated Pain (NRS): Primary Endpoint