Fibromyalgia: Milnacipran: A New Treatment Option for Fibromyalgia
by Philip J. Mease, MD
On January 14, 2009 the Food and Drug Administration approved the use of SavellaTM
(milnacipran) for the treatment of fibromyalgia. This third approved drug offers health
care providers yet another treatment option for their fibromyaliga patients. Dr. Philip
Mease’s detailed article covers the scientific specifics of Savella’s efficacy
in a fibromyalgia treatment regimen and offers the promise of a better quality of life for
people living with this chronic pain condition.
— Rae Marie Gleason
Department Head
On January 14, 2009, milnacipran (SavellaTM, Forest Pharmaceuticals, Inc.) was approved
by the U.S. Food and Drug Administration (FDA) for the treatment of fibromyalgia (FM), a
chronic disorder that affects an estimated 2%-4% of the US population and primarily occurs
in women.1,2 The approval of milnacipran represents continued progress in the
development of medications to manage this disorder. This approval was based on the results
of several large clinical trials, using novel composite endpoints that demonstrated the
benefits of milnacipran for not only pain, but also the patient’s overall
fibromyalgia experience and function. The drug has been generally well tolerated. Detailed
discussion of the drug’s pharmacology, efficacy, and safety data is provided. The FDA
approval of milnacipran (SavellaTM) for the treatment of fibromyalgia is a welcome
development. Milnacipran joins two other medications approved for the management of FM:
pregabalin (Lyrica«, Pfizer, Inc.) and duloxetine (Cymbalta«, Eli Lilly & Co.).
In 1990, the American College of Rheumatology (ACR) published classification criteria
for FM that were based on the symptom of chronic widespread pain.3 These
criteria require the presence of pain for at least 3 months in all 4 quadrants of the
body, as well as the presence of pain in 11 of 18 tender points upon digital palpation.
Although the ACR criteria have been adapted by researchers and physicians, their
usefulness in clinical practice may be limited.2,4 One major limitation is that
the criteria focus on pain and do not address the other symptoms of FM, thereby failing to
capture the complexity of this disorder. As reported in an internet survey of FM patients
that was conducted in collaboration with the National Fibromyalgia Association (NFA),5
other common symptoms include stiffness, fatigue, sleep problems, cognitive dysfunction,
anxiety, and depressed mood.
The importance of assessing the multiple symptoms of FM in clinical research is being
addressed by the working group of Outcome Measures in Rheumatology (OMERACT). Patients and
clinician-investigators achieved consensus on key domains to be assessed in clinical
trials of FM, such as pain, fatigue, impaired multidimensional function, sleep
disturbance, cognitive dysfunction, mood disorder, stiffness, and tenderness.6,7
In collaboration with the World Health Organization’s (WHO) International
Classification of Functioning Disability and Health (ICF) and the US National Institutes
of Health’s Patient Reported Outcome Measures Information System network (PROMIS),
work is under way to develop more specific and sensitive instruments to measure these
symptom domains and to demonstrate change with effective therapy. One method currently on
the OMERACT agenda is the use of a composite responder index, which can simultaneously
assess clinically-meaningful improvements in pain and other FM-associated symptoms in one
outcome.6 In contrast to outcomes that only allow for comparisons among
treatment groups in a single domain (e.g., pain scores, patient global changes, or
function), composite responder rates identify the proportion of individual patients in a
treatment group who experience simultaneous improvements in multiple domains.6,8
The phase three clinical trials of milnacipran used composite responder analyses as
primary endpoints, pioneering this approach in FM.
Please refer to the May 2009 issue for the complete text. In the event you need to order a back issue, please click here.
— May 2009
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