Introduction:
Last Updated 2 September 2010 Fibromyalgia affects an estimated 16 million people across
the major pharmaceutical markets and is one of the most common chronic pain
disorders. Despite the large prevalent population, fibromyalgia has
traditionally been a disorder that is under-recognized by the medical
community, characterized by low diagnosis rates and lack of approved therapies.
Although three agents are now approved for fibromyalgia in the United States,
none are approved in Europe and Japan, and no one agent offers an ideal balance
of safety and efficacy; therefore, significant opportunity remains in this
market.
Questions Answered in This Report:
*
In all markets under study, experts interviewed report that
less than one-third of the fibromyalgia prevalent population is properly
diagnosed.
How will diagnosis rates change over the study period? What will
be the growth of the drug-treated population in Europe and Japan, where no
agents are yet approved to treat fibromyalgia? What effect will the new,
preliminary diagnostic criteria have on diagnosis? What other factors are
contributing to changing diagnosis rates across the major markets?
*
U.S. experts tell us that they are treating an increasing
number of patients with fibromyalgia-approved
agents—pregabalin
(Pfizer’s Lyrica),
duloxetine
(Eli Lilly/Boehringer Ingelheim’s
Cymbalta/Xeristar/Ariclaim), milnacipran (Forest Laboratories’ Savella)—instead
of older agents (e.g., amitriptyline [generics]) that were once first-line
treatments.
Into which lines of therapy are these fibromyalgia-approved
agents being incorporated? How does the availability of inexpensive,
generically available therapies affect the use of pregabalin, duloxetine, and
milnacipran? Has one agent emerged as the clinical gold standard for first-line
treatment?
*
Although approved in the United States, duloxetine
, pregabalin,
and milnacipran received negative opinions in Europe on approval of
fibromyalgia.
What do physicians say about the lack of approved agents in
Europe? How does lack of approval influence use of duloxetine, pregabalin, and
milnacipran in Europe? Will any drugs launch for fibromyalgia in Europe during
the forecast period?
*
Only one novel agent is in late-stage development for
fibromyalgia and has filed for approval with the FDA and European Medicines
Agency: sodium oxybate, Jazz Pharmaceuticals/UCB’s JZP-6, currently marketed as
Xyrem.
What are interviewed experts saying about this agent? How will the
FDA advisory committee’s recommendation to deny approval affect the FDA’s
review? Do we expect this agent to receive approval for fibromyalgia during our
forecast period in the United States or Europe?Scope:
Markets covered: United States, France, Germany,
Italy, Spain, United Kingdom, Japan.
Primary research: 29 country-specific interviews with
fibromyalgia experts, rheumatologists, psychiatrists, neurologists, and pain
specialists.
Epidemiology: Prevalence of fibromyalgia with and
without comorbid depression.
Emerging therapies: Phase II: 7 drugs; Phase
III/IV: 6 drugs. Coverage of 3 select preclinical and Phase I products.
Market forecast features: Using market research, primary
research with key opinion leaders, and our proprietary forecasting model, we
provide an in-depth examination of current and future fibromyalgia
diagnosis/drug-treatment trends and market performance over a ten-year forecast
period (2009-2019).
Alternative market scenario: (1) Jazz Pharmaceuticals/UCB’s
sodium oxybate (JZP-6, currently marketed as Xyrem) is issued a complete
response letter from the FDA for fibromyalgia in the United States and
ultimately gains approval during our forecast period. (2) Jazz
Pharmaceuticals/UCB’s sodium oxybate is issued a complete response letter from
the FDA for fibromyalgia in the United States and, in time, is able to gain
approval for the condition in both the United States and Europe.