Flexeril for OTC use

8/10/99


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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

Author: witter