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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 treatment
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 treatment, health care professionals now have an
easy-to-administer treatment 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 approval of AMRIX, were pooled from two identical 14-day
randomized, double-blind, placebo-controlled, multicenter studies,
evaluating a total of 504 adults across four study 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 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
Datele din douã studii clinice pivot de AMRIX, Un nou-o datã pe zi, cu eliberare prelungitã musculare Relaxant, prezentate la Academiei Americane de dureri de întâlnire medicina - Data From Two Pivotal Trials Of AMRIX, A New Once-Daily Extended-Release Muscle Relaxant, Presented At The American Academy Of Pain Medicine Meeting - articole medicale engleza - startsanatate