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Study Reports: ULTRACET Effective for Treating Fibromyalgia Pain

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www.ProHealth.com • July 2, 2003


Announcement from The National Fibromyalgia Association

Orange, CA, June 12, 2003 - The National Fibromyalgia Association (NFA) announced today that a recent study published in the American Journal of Medicine reports that ULTRACET (tramadol hydrochloride/ acetaminophen) has been found to effectively reduce pain in people with fibromyalgia.

Currently there are no medications approved for the treatment of fibromyalgia in the U.S., so the study's findings provide significant hope for patient's searching for ways to effectively manage the chronic pain of this severe disorder.

Fibromyalgia (FM) is a complex chronic pain illness that can lead to significant patient disability. The fact that there is no known cause or cure for fibromyalgia challenges patients and healthcare professionals alike. It is estimated that FM affects approximately six to eight million Americans and 5% of the world's population. Patients with fibromyalgia suffer from a variety of symptoms ranging from stiffness, muscle spasms and body wide pain, fatigue and severe sleep disturbances.

The study published in the American Journal of Medicine was lead by researcher Robert M. Bennett, M.D., a pain specialist at the Oregon Health and Science University. He compared ULTRACET (37.5 mg tramadol hydrochloride/325 mg acetaminophen tablets) to placebo in 315 fibromyalgia patients. Patients who used ULTRACET experienced significantly better pain relief, as indicated by statistical analysis, than those who received placebo.

Although Ultracet has received some exposure in the medical industry, not all physicians know about it. "A lot of patients actually have to educate their doctor," notes Bennett, "but they might want to do it diplomatically," he adds.

In the U.S., ULTRACET is approved for the treatment of short-term (five days or less) management of acute pain. The efficacy of ULTRACET in treating pain is based on the value of the drug's two components-tramadol hydrochloride and acetaminophen.

About Fibromyalgia:

Fibromyalgia is a chronic pain disorder that affects people of all genders and ages. The condition is identified by widespread severe musculoskeletal pain, fatigue, and tenderness in localized areas. These areas, called "tender points," can be palpated in the head, neck, shoulder region, arms, hands, lower back, hips, thighs, and knees.

Although physicians have noted the existence of fibromyalgia symptoms in patients for centuries, it was only recognized as a medical disorder during the 1980s. The American College of Rheumatology set up diagnostic for criteria for the condition in 1990. Diagnosis is difficult as it relies on the patient's ability to rate his or her own pain and as of yet, cannot be quantified by laboratory tests. Further complicating diagnosis, fibromyalgia pain can also be accompanied by other conditions including irritable bowel syndrome, restless leg syndrome, Raynaud's syndrome and depression.

Physicians prescribe a variety of medications in an attempt to alleviate the patients' symptoms, as there is no single successful treatment for fibromyalgia. Current treatment options for pain associated with fibromyalgia include physical therapy, nonsteroidal anti-inflammatory drugs and muscle relaxants that may provide temporary relief.

Study Details

This 91-day, multi-center, outpatient, double-blind, randomized, placebo-controlled study compared ULTRACET tablets to placebo. Outcome variables included cumulative time to discontinuation (Kaplan-Meier analysis), final pain visual analog scale scores, final pain relief rating scale scores, total tender points, average myalgic scores, SF-36 Health Survey scores and Fibromyalgia Impact Questionnaire scores.

These scales were used for overall statistical analysis and to evaluate patient responses.

Of 315 patients randomized, 313 (294 women [94%], mean age 50 + 10) completed >1 post-randomization efficacy assessments (n = 156 tramadol/acetaminophen; n = 157 placebo). The Kaplan-Meier analysis of final discontinuation rates for any reason demonstrated significantly better performance with ULTRACET compared with placebo (P = 0.004). ULTRACET patients had significantly better final pain visual analog scale scores, final pain relief rating scale scores, and total Fibromyalgia Impact Questionnaire scores. SF-36 indices of physical functioning, role-physical, body pain, health transition, and physical component summary all improved significantly in the ULTRACET patients, indicating statistically significantly higher levels of pain relief in patients taking ULTRACET than placebo.

Adverse event discontinuation occurred in 19% (29/156) of ULTRACET and 12% (18/156) of placebo patients. The most common treatment-emergent adverse events in the ULTRACET vs. placebo groups were nausea (20% vs. 12%), headache (14% vs. 10%), and pruritus (12% vs. 4%). The average dose of ULTRACET was 4.0 tablets/day (+ 1.8). ULTRACET tablets contain 37.5 mg tramadol hydrochloride and 325 mg acetaminophen.

About ULTRACET

ULTRACET combines tramadol, a leading prescription pain reliever, with acetaminophen, the most commonly recommended nonprescription pain treatment. Single-dose dental pain studies demonstrated that the ULTRACET combination of tramadol and acetaminophen provides faster onset than tramadol alone as well as longer duration and better pain relief over either medication alone.

Tramadol is a non-scheduled, centrally acting synthetic opioid analgesic. Acetaminophen is a non-opiate, non-salicylate analgesic that is often combined with other medications to enhance efficacy. ULTRACET was approved in the U.S. in August 2001.

ULTRACET is indicated for the short-term (five days or less) management of acute pain.

ULTRACET is a centrally acting analgesic that controls pain via different mechanisms of action than non-steroidal anti-inflammatory drugs (NSAIDs), the most commonly used pain medications.

ULTRACET is not an NSAID, and is not associated with potentially life-threatening gastrointestinal ulcers or bleeding that can occur with NSAIDs and the newer COX-2 NSAIDs. In addition, ULTRACET does not compromise the efficacy of certain antihypertensive agents, while NSAIDs and COX-2 NSAIDs may. ULTRACET can also be prescribed in sulfa-sensitive patients. The most frequently reported side effects with ULTRACET listed in the prescribing information are constipation (6%), somnolence (sleepiness) (6%), and increased sweating (4%).

ULTRACET should not be used concomitantly with alcohol. The use of ULTRACET in patients with liver disease is not recommended.

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FOR MORE INFORMATION CONTACT: Lynne Matallana, President - National Fibromyalgia Association - (714) 921-0150 - LMatallana@fmaware.org



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