Pfizer's Pregabalin effective in pain treatment - study
Pfizer Inc's Pregabalin was shown to provide improvement of pain in patients with fibromyalgia, a chronic and debilitating pain syndrome, according to a study presented yesterday 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 2% 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.
According to the study, Pregabalin-treated patients showed statistically significant improvements in pain compared to those who received placebo. Further, 29% of pregabalin-treated patients reported at least a 50% reduction in pain, compared with a reduction of 13% for patients who received placebo, a difference that was statistically significant.
In addition, pregabalin significantly improved sleep quality and fatigue.
Developed by Pfizer, Pregabalin has been studied in an extensive clinical program involving over 8,000 patients worldwide.
The company said it 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.
