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New Data Suggest Cymbalta(R) Reduced Pain in Fibromyalgia Patients With and Without Depression

Tuesday, August 21, 2007 General News
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INDIANAPOLIS, Aug. 21 New data suggest thatpatients with fibromyalgia treated with 60mg or 120mg of Cymbalta(R)(duloxetine HCl) experienced greater reduction in pain severity beginning oneweek after starting duloxetine than those taking placebo (sugar pill), asmeasured by the Brief Pain Inventory Average Pain Score (BPI). The study,which included patients with and without depression, also showed greaterimprovements in patients taking duloxetine than in those taking placebo inscores on the Patient's Global Impression of Improvement questionnaire (PGI-I), which measures how the patient has felt overall since beginning to takethe medication. The data were presented today at the 2007 Congress of theInternational MYOPAIN Society in Washington, D.C.
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At three months, patients treated with 60mg per day or 120mg per day ofduloxetine showed significantly greater reduction in pain and improvement inPGI-I scores compared with patients taking placebo. At three months, morepatients treated with either 60mg or 120mg of duloxetine showed significantlygreater reduction in pain as measured by a 30 percent improvement in baselineBPI scores (50.7 percent and 52.1 percent, respectively) compared withpatients taking placebo (36 percent).
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"Fibromyalgia is a chronic illness, characterized by widespread pain,tenderness and fatigue. It can also affect the patient's overall emotionalhealth and well-being," said I. Jon Russell, M.D., Ph.D., associate professorof medicine at the University of Texas Health Science Center in San Antonio."Between 34 percent(1) and 62 percent(2) of those living with fibromyalgiawill experience depression at some point in their lives. In this study, whichincluded patients with and without depression, duloxetine reduced the painassociated with fibromyalgia."

Fibromyalgia is estimated to affect 2 percent to 4 percent of the U.S.population(3), the majority being women. In addition to chronic pain,fibromyalgia patients often have complaints about cloudy thinking, morningstiffness and overall inability to function in their everyday lives.

Fibromyalgia sNDA Submitted to FDA

Eli Lilly and Company (NYSE: LLY) also announced today that it recentlysubmitted a supplemental new drug application (sNDA) to the U.S. Food and DrugAdministration (FDA) for Cymbalta for the management of fibromyalgia. The sNDAsubmission is based on data from approximately 1,400 patients in five clinicaltrials.

"Lack of awareness of fibromyalgia can lead to frustration as patientsoften see multiple physicians over a number of years before receiving a formaldiagnosis," said Alan Breier, M.D., vice president for medical and chiefmedical officer, Eli Lilly and Company. "This research may help increaserecognition of fibromyalgia and offer hope to those living with thisdebilitating condition."

About Cymbalta

Serotonin and norepinephrine in the brain and spinal cord are believed toboth mediate core mood symptoms and help regulate the perception of pain.Based on pre-clinical studies, duloxetine is a balanced and potent reuptakeinhibitor of serotonin and norepinephrine that is believed to potentiate theactivity of these chemicals in the central nervous system (brain and spinalcord). While the mechanism of action of duloxetine is not fully known,scientists believe its effects on depression and anxiety symptoms, as well asits effect on pain perception, may be due to increasing the activity ofserotonin and norepinephrine in the central nervous system.

Cymbalta is approved in the United States for the treatment of majordepressive disorder (MDD), the management of diabetic peripheral neuropathicpain (DPNP) and the treatment of generalized anxiety disorder (GAD), all inadults (age 18+). Cymbalta is not approved for use in pediatric patients.

Important Safety Information

Cymbalta is approved to treat major depressive disord
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