Flexeril OTC

8/10/99


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Table of Contents

Flexeril OTC

Issues

Sedation

Can Flexeril produce sedation without psychomotor impairment?

Psychomotor Function Trials

STUDY 012

Study Objective

Design

Results

Results (cont.)

Conclusions

STUDIES 001, 002, 003

Study 001

Study 002

Study 003

Assessments

Assessments Psychomotor testing performed 2 hours post dosing

Summary of Design and Analysis Problems

Results 001, 002, and 003

Conclusions

Conclusions (cont.)

Studies 014 & 015

Studies 014 and 015

Study Populations

Assessments

Results of Studies 014 and 015

Results of Study 014 Vigilance Task

Conclusions

Overall Conclusions

Overall Conclusions (cont.)

Author: CDER User