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

No Therapies Approved for Chronic Pain Associated with Fibromyalgia;

Poor Sleep and Fatigue Also Characterize Condition

Oct 25, 2002, 01:00 ET from Pfizer Inc

    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
     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. Leslie 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.
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