Market Wire - New Data Suggest Cymbalta(R) Reduced Pain in Fibromyalgia Patients With and Without Depression
New data suggest that patients with
fibromyalgia treated with 60mg or 120mg of Cymbalta (duloxetine HCl)
experienced greater reduction in pain severity beginning one week after
starting duloxetine than those taking placebo (sugar pill), as measured by
the Brief Pain Inventory Average Pain Score (BPI). The study, which
included patients with and without depression, also showed greater
improvements in patients taking duloxetine than in those taking placebo in
scores on the Patient’s Global Impression of Improvement questionnaire
(PGI-I), which measures how the patient has felt overall since beginning to
take the medication. The data were presented today at the 2007 Congress of
the International MYOPAIN Society in Washington, D.C.
At three months, patients treated with 60mg per day or 120mg per day of
duloxetine showed significantly greater reduction in pain and improvement
in PGI-I scores compared with patients taking placebo. At three months,
more patients treated with either 60mg or 120mg of duloxetine showed
significantly greater reduction in pain as measured by a 30 percent
improvement in baseline BPI scores (50.7 percent and 52.1 percent,
respectively) compared with patients taking placebo (36 percent).
“Fibromyalgia is a chronic illness, characterized by widespread pain,
tenderness and fatigue. It can also affect the patient’s overall emotional
health and well-being,” said I. Jon Russell, M.D., Ph.D., associate
professor of medicine at the University of Texas Health Science Center in
San Antonio. “Between 34 percent(1) and 62 percent(2) of those living with
fibromyalgia will experience depression at some point in their lives. In
this study, which included patients with and without depression, duloxetine
reduced the pain associated 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, morning
stiffness and overall inability to function in their everyday lives.
Additional Study Highlights
– At six months, patients taking duloxetine 60mg or 120mg maintained
reduced BPI scores and patients taking 120mg had improved PGI-I scores
compared with those taking placebo.
– At the end of the six-month trial, more patients treated with both
60mg or 120mg of duloxetine showed a response to treatment, defined as a 50
percent reduction of baseline BPI scores (32.6 percent and 35.9 percent of
patients, respectively), compared with patients taking placebo (21.6
percent).
– Discontinuation rates over six months were similar among the groups
(45.3 percent and 46.3 percent for duloxetine 60mg and 120mg patients,
compared with 50 percent for placebo).
— Adverse event-related discontinuation was significantly higher in
patients taking 120mg (26.5 percent) but not in the 60mg (15.3 percent)
group as compared with placebo (13.2 percent). Discontinuations due to
lack of efficacy were not statistically different among treatment
groups.
— Adverse events were similar to those seen in prior duloxetine studies.
In this study, the most common adverse events (occurred at a rate of
greater than or equal to 5 percent and at least twice the rate of
placebo) included nausea, dry mouth, constipation, somnolence
(sleepiness), fatigue, insomnia, decreased appetite, hyperhydrosis,
cough, tremor, rash and weight increase.
Fibromyalgia sNDA Submitted to FDA
Eli Lilly and Company (NYSE: LLY) also announced today that it recently
submitted a supplemental new drug application (sNDA) to the U.S. Food and
Drug Administration (FDA) for Cymbalta for the management of fibromyalgia.
The sNDA submission is based on data from approximately 1,400 patients in
five clinical trials.
“Lack of awareness of fibromyalgia can lead to frustration as patients
often see multiple physicians over a number of years before receiving a
formal diagnosis,” said Alan Breier, M.D., vice president for medical and
chief medical officer, Eli Lilly and Company. “This research may help
increase recognition of fibromyalgia and offer hope to those living with
this debilitating condition.”
About Cymbalta
Serotonin and norepinephrine in the brain and spinal cord are believed to
both mediate core mood symptoms and help regulate the perception of pain.
Based on pre-clinical studies, duloxetine is a balanced and potent reuptake
inhibitor of serotonin and norepinephrine that is believed to potentiate
the activity of these chemicals in the central nervous system (brain and
spinal cord). While the mechanism of action of duloxetine is not fully
known, scientists believe its effects on depression and anxiety symptoms,
as well as its effect on pain perception, may be due to increasing the
activity of serotonin and norepinephrine in the central nervous system.
Cymbalta is approved in the United States for the treatment of major
depressive disorder (MDD), the management of diabetic peripheral
neuropathic pain (DPNP) and the treatment of generalized anxiety disorder
(GAD), all in adults (age 18). Cymbalta is not approved for use in
pediatric patients.
