Table of Contents
Flexeril for OTC use
FDA speakers
Muscle Relaxants-History
March 1995: AC meeting
Muscle Relaxants-Issues 1
Muscle Relaxants-Issues 2
Muscle Relaxants-Issues 3
Muscle Relaxants-Issues 4
Muscle Relaxants-Issues 5
Clinical Studies for OTC
OTC-Flexeril: Clinical Studies
Phase 3-Study Design
Concomitant Therapies
Studies 6 and 8-Patients
Primary endpoints
Results - Pt global, visit 3
Secondary results - spasm
Results-MD spasm, Visit 3
OTC: Efficacy/Effectiveness
Flex 5-OTC issues
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