Data From Two Pivotal Trials Of AMRIX, A New Once-Daily Extended-Release Muscle Relaxant, Presented At The American Academy Of Pain Medicine Meeting

Cephalon, Inc. (Nasdaq: CEPH) announced the pooled analysis of two pivotal randomized, placebo-controlled clinical trials showing that AMRIX(R) (cyclobenzaprine hydrochloride extended-release capsules), a new once-daily extended-release skeletal muscle relaxant, was superior to placebo. AMRIX had similar efficacy to cyclobenzaprine immediate-release (CIR) taken three times a day in alleviating acute muscle spasm associated with lower back and neck pain. In addition, less daytime drowsiness was observed with AMRIX compared to CIR, although such a comparison was not pre-specified in the statistical analysis plan. These results were presented at the 24th Annual Meeting of the American Academy of Pain Medicine in Orlando, FL.

"Typically, muscle relaxants are taken multiple times a day, which can make it difficult for some of my patients with acute muscle spasm associated with lower back and neck pain to adhere to their medical care regimen," said Arnold J. Weil, MD, of Non-Surgical Orthopaedics in Atlanta, GA, and the lead investigator in these studies. "With data supporting AMRIX as an effective once-daily medical care, health care professionals now have an easy-to-administer medical care option to offer their patients who are suffering from acute muscle spasm."

The data, which were the basis for the U.S. (Food and Drug Administration) acceptance of AMRIX, were pooled from two identical 14-day randomized, double-blind, placebo-controlled, multicenter studies, evaluating a total of 504 adults across four meditate arms (AMRIX 15 mg, AMRIX 30 mg, placebo, and CIR 10 mg three times daily). These participants had moderate-to-severe muscle spasm of cervical or lumbar origin associated with local pain, tenderness, limitation of motion, and restrictions of daily living. In these studies, patients and physicians assessed how helpful the medication was in the medical care of acute muscle spasm. Primary endpoints of the clinical trials were Patient's Rating of Medication Helpfulness at day four of medical care and Physician's medical institution al 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