Efficacy in pivotal trials

Efficacy and safety were assessed in 2 identical, phase 3, multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group, 4-arm trials with 14 days of treatment.³ 

• Primary endpoints were patient’s rating of medication helpfulness and physician's clinical global assessment at day 4

Proven efficacy with once-daily dosing^1,3

Patient's Rating of Medication Helpfulness at Day 4 (N=504)^a

• AMRIX demonstrated a statistically significant difference in patient’s rating of medication helpfulness vs placebo at day 4
• No statistically significant difference in physician’s clinical global assessment was demonstrated with AMRIX vs placebo
• No statistically significant difference in either primary endpoint between AMRIX and cyclobenzaprine IR 10 mg 3 times daily

AMRIX is contraindicated in patients who are hypersensitive to any of its components. AMRIX is contraindicated with concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation. AMRIX may have life-threatening interactions with MAO inhibitors. AMRIX is contraindicated during the acute recovery phase of myocardial infarction; in patients with arrhythmias, heart block conduction disturbances, or congestive heart failure; or in patients with hyperthyroidism. AMRIX may enhance the effects of alcohol, barbiturates, and other CNS depressants. AMRIX should not be used in elderly patients or in patients with impaired hepatic function.

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