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April 15, 2003
New, Less-Sedating Dose Offers Relief for Millions Who Suffer From Low-Back Pain
Fort Washington, PA (April 14, 2003) – McNeil Consumer & Specialty Pharmaceuticals announced today that FLEXERIL® (cyclobenzaprine HCl) 5 mg tablets, the newly approved muscle relaxant, are now on pharmacists' shelves across the nation. FLEXERIL® 5 mg tablets are a new lower-dose, less-sedating version of the most frequently prescribed muscle relaxant. The Food and Drug Administration approved FLEXERIL® 5 mg on February 4, 2003, as a two-three week adjunct to rest and physical therapy for the relief of muscle spasm associated with acute, painful musculoskeletal conditions.
Until now, cyclobenzaprine HCl, the active ingredient in FLEXERIL® 5 mg, has been available only in 10 mg tablets. "FLEXERIL® 5 mg relieves muscle spasm pain with a lower incidence of side effects than the 10 mg tablet," explained Gary Ruoff, M.D., clinical professor of family practice, Michigan State University College of Human Medicine. In a clinical study versus placebo, each dosage strength of FLEXERIL® demonstrated an ability to relieve muscle spasm pain, but patients taking FLEXERIL® 5 mg reported significantly less drowsiness than patients taking the 10 mg tablet.
The effectiveness of FLEXERIL® 5 mg was demonstrated in two seven-day, double-blind, placebo-controlled, randomized, multi-center clinical trials enrolling 1,405 patients with acute (<14 days), physician-rated moderate or moderately severe painful muscle spasm in the lower back or neck. Concomitant use of analgesics, psychotropic agents and drugs with the potential to cause sedation were prohibited.
Over a one-week course of treatment, patients reported that FLEXERIL® 5 mg provided relief of musculoskeletal spasm symptoms significantly greater than placebo. On average, most patients experienced some, a lot, or complete symptom relief within 48 hours of starting treatment with both the 5 mg and 10 mg strengths of FLEXERIL®.
The incidence of sedation was significantly lower in patients taking FLEXERIL® 5 mg compared with those taking FLEXERIL® 10 mg (29 percent versus 38 percent, respectively; 10 percent for placebo). Most patients who reported sedation developed it on the first or second day of dosing. Most episodes were mild and did not result in discontinuation of therapy. Only two percent of patients reported severe sedation.
Dry mouth, another side effect associated with most muscle relaxants, was also significantly lower in the FLEXERIL® 5 mg patient group compared with the FLEXERIL® 10 mg group (21 percent versus 32 percent, respectively; 7 percent for placebo). Other adverse events reported in greater than three percent of patients include fatigue and headache.
Musculoskeletal Pain
Approximately 15 percent to 20 percent of the U.S. population suffers from low back pain in any given year, and according to the federal Agency for Health Care Policy and Research, about two-thirds have low back pain at some point in their lives. In fact, low back pain is the most frequent cause of disability in people under age 45. It is estimated that up to half of all working adults experience back pain each year. Including disability and lost days of work, low back pain accounts for $50 billion in costs annually.
FLEXERIL® should not be taken by patients during acute recovery phase of myocardial infarction or by patients with arrhythmias, heart block, conduction disturbances, congestive heart failure, allergies to cyclobenzaprine or other ingredients in FLEXERIL®, hyperthyroidism, current or recent use (within 14 days after discontinuation) of monoamine oxidase inhibitors (MAOIs). FLEXERIL® may enhance the effects of alcohol, barbiturates and other CNS depressants. FLEXERIL® may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle.
Hyperpyretic crisis seizures and deaths have occurred in patients receiving cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitor drugs. Cycolbenzaprine is closely related to the tricyclic antidepressants, which have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction, and stroke. Because of its atropine-line action, FLEXERIL® should be used in caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure and in patients taking anticholinergic medication.
Please see full U.S. Prescribing Information or consult www.flexeril.info for more information. For more information about FLEXERIL® 5 mg, call 1-888-440-7903.
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