Fibromyalgia

Pharmacor -- August 2007

  Introduction:

Pharmaceutical developers are just beginning to capitalize on the opportunity to help millions of fibromyalgia patients. The arrival of drugs with regulatory labeling for fibromyalgia and the attendant marketing and increased awareness of fibromyalgia will quadruple the size of this relatively new drug market. Success in this market will depend on marketers’ ability to win over regulators, payers, and a patient population that is particularly sensitive to the side effects of drug therapy.

  Questions Answered in This Report:

Fibromyalgia is now recognized by experts and regulators as a disorder of central nervous system pain processing, and the disorder is now recognized more broadly as a candidate for drug therapy. Which agents are most widely used to treat the disorder? What are their shortcomings? How might drug developers capitalize on fibromyalgia patients’ need for drug therapy?

Pregabalin (Pfizer’s Lyrica) received FDA approval for the treatment of fibromyalgia in June 2007. Pregabalin is the first drug to receive labeling for fibromyalgia. Four other products are in Phase III trials for the disorder. Which other agents are likely to follow pregabalin into this market? To what extent will regulatory labeling expand pregabalin’s use in fibromyalgia? How will competing drugs differentiate themselves?

Thought-leading physicians tell us that recognition and treatment of fibromyalgia have increased and will continue to increase over the next five years. Yet the percentage of cases recognized and treated with pharmaceuticals remains small. How large will the diagnosed and drug-treated populations grow? To what extent will fibromyalgia be managed in the primary care setting? Which agents will emerge as first- and second-line therapy?

Emerging agents in this market are patent-protected and higher-priced than many current drugs. To what extent will payers accept these newer therapies in the fibromyalgia market?

  Scope:

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: 22 country-specific interviews with thought leaders in fibromyalgia.

Epidemiology: Prevalence of fibromyalgia, including estimates of cases with and without comorbid depression.

Emerging therapies: Phase II: 4 drugs; Phase III: 4 drugs; registered: 1 drug.

Market forecast features: Using our Interactive Forecast Tool, we forecast population sizes and drug sales for fibromyalgia through 2016 in the major markets under study.