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FDA Approves Lower Dose Flexeril (Cyclobenzaprine) For Treatment Of Muscle Spasm

New, Less-Sedating Dose Offers Relief for Millions Who Suffer From Low-Back Pain

FORT WASHINGTON, PA -- February 4, 2003 -- The U.S. Food and Drug Administration has approved FlexerilŽ (cyclobenzaprine HCl) 5 mg tablets, a new lower-dose, less-sedating version of the most frequently prescribed muscle relaxant, as an adjunct to rest and physical therapy for the relief of muscle spasm associated with acute, painful musculoskeletal conditions. McNeil Consumer & Specialty Pharmaceuticals will market the product in the United States. It is expected to be available in pharmacies in April.

Until now, cyclobenzaprine HCl, the active ingredient in Flexeril 5 mg, has been available only in 10 mg tablets. Flexeril 10 mg is recognized as highly efficacious. 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.

"Musculoskeletal pain, particularly low back pain with muscle spasms, is a leading cause of physician visits," explained Bill McCarberg, M.D., Director, Chronic Pain Management Program, Kaiser Permanente, San Diego, Calif. "Because Flexeril 5 mg relieves muscle spasm pain with a lower incidence of side effects than the 10 mg tablet, physicians now have greater dosing flexibility for the initial treatment of sprains, strains, and other painful musculoskeletal injuries."

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, patients experienced some, a lot, or complete symptom relief within 48 hours of starting treatment with both strengths of Flexeril.

The incidence of sedation was significantly lower in patients taking Flexeril 5 mg compared with those taking Flexeril 10 mg (29% vs. 38%, respectively; 10% 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. "In clinical practice it has been found that a patient who does not experience sedation in the early stages of treatment, will mostly likely not experience drowsiness later in the course of treatment," noted Dr. McCarberg.

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% vs. 32%, respectively; 7% for placebo). Other adverse events reported in greater than three percent of patients include fatigue and headache.

Analysis of the data from controlled studies show that Flexeril produces clinical improvement whether or not sedation occurs. "The data demonstrate that the efficacy of Flexeril is not due to sedation," said Dr. McCarberg.

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.

Please see full U.S. Prescribing Information or consult http://www.flexeril.info for more information. For more information about Flexeril 5 mg, call 1-888-440-7903.


SOURCE: McNeil Consumer & Specialty Pharmaceuticals

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