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Cyclobenzaprine Extended-Release Tablets Superior to Placebo in Relieving Low Back and Neck Pain: Presented at AAPM

By Ed Susman

KISSIMMEE, FL -- February 18, 2008 -- The extended-release formulation of cyclobenzaprine hydrochloride (Amrix) demonstrated superior ability, compared with placebo, to bring pain relief to patients with low back and neck pain associated with muscle spasms, researchers reported here at the American Academy of Pain Medicine (AAPM) 24th Annual Meeting.

"Once-daily cyclobenzaprine extended-release 15 mg and 30 mg were superior to placebo and had similar efficacy to cyclobenzaprine immediate release (Flexeril) in alleviating acute muscle spasm," said Arnold Weil, MD, Head, Non-Surgical Orthopaedic & Spine Center, Marietta, Georgia, United States.

In a poster presentation on February 14, Dr. Weil said the extended-release formulation of cyclobenzaprine also appeared to cause less drowsiness than the immediate-release formulation of the muscle relaxant, although a comparison between the two formulations on that issue was not a prespecified target of the clinical trial.

Dr. Weil and colleagues recruited 504 patients aged 18 to 75 years presenting with severe muscle spasm, associated with pain, of the cervical or lumbar region. They randomly assigned 128 patients to placebo, 127 patients to cyclobenzaprine extended-release 15 mg once daily, 126 patients to cyclobenzaprine extended-release 30 mg once daily, and 123 patients to cyclobenzaprine immediate-release 10 mg 3 times daily.

"For each comparison of cyclobenzaprine extended release versus placebo, there was a statistically significant difference in the distribution of patients' rating of medication helpfulness," Dr Weil said. About 56% of patients said the relief from the 15-mg dose was "good, very good, or excellent" compared with 40% of patients getting placebo (P = .014).

About 59.7% of those receiving the 30-mg dose of cyclobenzaprine experienced good or better relief (P = .0002).

Physicians' clinical global assessment of patients' improvement showed a preference for treatment with cyclobenzaprine, but the difference between the drug and placebo did not reach statistical significance, Dr. Weil explained.

Funding for this study was provided by ECR Pharmaceuticals. Cephalon, Inc. acquired the North American rights to Amrix in August 2007.


[Presentation title: Efficacy of Cyclobenzaprine Hydrochloride Extended-Release 15 mg and 30 mg Once-Daily for Low Back and Neck Pain Associated With Muscle Spasms: A Pooled Analysis of Two Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Studies. Abstract 206]

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