Data from Two Pivotal Trials of AMRIX, a New Once-Daily Extended-Release Muscle Relaxant, Presented at the American Academy of Pain Medici...(In these studies patients and physicians...)

Date:2/14/2008

In these studies, patients and physicians assessed how helpful the medication was in the treatment of acute muscle spasm. Primary endpoints of the clinical trials were Patient's Rating of Medication Helpfulness at day four of treatment and Physician's Clinical Global Assessment at day four.

Study results of the Patient's Rating of Medication Helpfulness, a measure of efficacy, showed that a higher proportion of patients (p<0.025) taking AMRIX 15 mg (56.0 percent; n=116) and AMRIX 30 mg (56.7 percent; n=120) reported "good" to "excellent" responses compared with the placebo group (40.0 percent; n=115) at day four. The distribution of responses for AMRIX and CIR was similar. The trials did not demonstrate significant differences among the study groups on the Physician's Clinical Global Assessment at day four.

In a scale of Patient-Rated Daytime Drowsiness at day four, more patients in the AMRIX groups (15 mg, 50.4 percent, and 30 mg, 42.1 percent) had "no to very little" drowsiness compared with the CIR group (28.8 percent). As expected, more patients in the AMRIX groups had daytime drowsiness compared with placebo.

The majority of all adverse events reported in these trials were mild in intensity. The most common side effects of AMRIX (greater than or equal to three percent) were dry mouth, dizziness, fatigue, nausea, and constipation. Somnolence (a state of drowsiness) was the most common adverse event leading to discontinuation (two patients in the AMRIX 30 mg group and eight in the CIR group).

About AMRIX

AMRIX is indicated for short-term use (up to two or three weeks) for relief of muscle spasm associated with acute, painful musculoskeletal conditions. The first and only once-daily muscle relaxant, AMRIX is available in 15 and 30 mg dosage strengths.

AMRIX is contraindicated with concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation; in patients during the acute recovery phase
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SOURCE Cephalon, Inc. Copyright©2008 PR Newswire. All rights reserved

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