Pfizer's Pregabalin Significantly Improves Pain In Fibromyalgia Patients, New Data Show

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No Therapies Approved for Chronic Pain Associated with Fibromyalgia;

Poor Sleep and Fatigue Also Characterize Condition

NEW ORLEANS, Oct. 25 /PRNewswire-FirstCall/ -- Pfizer Inc's pregabalin

was

shown to provide improvement of pain in patients with fibromyalgia, a

chronic

and debilitating pain syndrome, according to data presented here today at

the

annual meeting of the American College of Rheumatology.

Pregabalin also was shown to improve sleep and fatigue levels, the data

demonstrate.

Fibromyalgia syndrome (FMS) is a chronic disorder characterized by

widespread musculoskeletal pain that is frequently associated with fatigue

and

sleep disturbances. It is estimated to affect two percent of the

population,

or 5.6 million Americans, and occurs most frequently in women.

The double-blind, placebo-controlled monotherapy study involved

529 patients diagnosed with FMS. Patients were randomized to receive

placebo

or pregabalin (150 mg, 300 mg or 450 mg per day) for eight weeks. The study

evaluated the efficacy and safety of pregabalin for the treatment of pain

and

associated symptoms such as sleep and fatigue. Patients were required to

characterize and record their pain on a daily basis in detailed diaries.

Pregabalin-treated patients (450 mg/day) showed statistically

significant

improvements in pain compared to those who received placebo. Further,

29 percent of pregabalin-treated patients reported at least a 50 percent

reduction in pain, compared with a reduction of 13 percent for patients who

received placebo, a difference that was statistically significant. In

addition, pregabalin significantly improved sleep quality and fatigue.

" To demonstrate improvements in the core symptoms of FMS -- pain, sleep

and fatigue -- represents an important advance, particularly as there are no

approved treatments for this condition, " said Dr. Crofford, lead

investigator and associate professor of internal medicine, Division of

Rheumatology, at the University of Michigan in Ann Arbor.

" FMS is highly debilitating for patients and difficult to treat, and we

are in need of new treatment options that are both effective and well

tolerated, " Dr. Crofford said. " These data are highly encouraging because

pregabalin was shown to provide significant relief from the most troublesome

symptoms for patients. "

The most common dose-related side effects reported by patients were

dizziness and drowsiness. Most adverse events were mild to moderate in

intensity, and many resolved during the study. Seventy-eight percent of all

patients completed the study.

Developed by Pfizer, pregabalin has been studied in an extensive

clinical

program involving over 8,000 patients worldwide. The company has completed

pivotal studies to support the filing of a New Drug Application for

pregabalin

for the treatment of neuropathic pain and generalized anxiety disorder and

as

an add-on therapy for epilepsy.

Pfizer Neuroscience is committed to pioneering innovative therapies for

neurological and psychiatric disorders. Pfizer's experience in the areas of

depression, anxiety, schizophrenia, Alzheimer's disease and epilepsy has

helped bring leading medicines to market for the treatment of these

disorders.

Neurological and psychiatric disorders represent an important priority

in

Pfizer's $5.2 billion development effort, with more than 20 percent of the

company's research and development budget allocated to finding more

effective

neuroscience medicines for mood and anxiety disorders, migraine, pain,

epilepsy and smoking cessation.

Pfizer Inc discovers, develops, manufactures and markets leading

prescription medicines for humans and animals and many of the world's

best-known consumer brands.