Expert: Daniel Clauw, MD, professor of medicine at the University of Michigan and executive director of the university’s Chronic Pain and Fatigue Research Center and the Center for the Advancement of Clinical Research

Q: The approval of pregabalin (Lyrica) for fibromyalgia was hailed as an important advance. Why is that?

A: In approving Lyrica for fibromyalgia, the FDA legitimized fibromyalgia as a real entity. The new approval may broaden the number of fibromyalgia patients for whom doctors will use Lyrica, meaning more people with chronic pain may find relief.

Q: Is there any way to avoid the negative side effects of Lyrica
A: Many doctors suggest breaking the dose up so the lion's share is taken at night. If you are taking 300 mg a day, your doctor may suggest taking 100 mg in the morning and 200 mg at night, since it doesn’t really matter if you are tired or light-headed while you are sleeping.

Q: Is Lyrica the first of many new fibromyalgia treatments to come?

A: Two more new drugs may get nods for FDA approval in the next year. Two of the drugs showing benefit for people with fibromyalgia are members of a new class of drugs known as norepinephrine serotonin reuptake inhibitors (NSRIs). These drugs affect levels of two brain chemicals, norepinephrine and serotonin, which play a role in pain and mood. Milnacipran is one of those NSRIs. The other – duloxetine (Cymbalta) – is already prescribed off-label for fibromyalgia and has FDA approval for major depression, generalized anxiety disorder and nerve pain.

Q: How will having a treatment option that is specific to fibromyalgia improve treatment of the condition overall?
A: When we use drugs, exercise, cognitive behavior therapy and education, we can manage fibromyalgia in a significant number of patients, but unfortunately that's not what has been done in routine care. Many physicians haven’t known what to use to treat fibromyalgia. They’ll use non-steroidal anti-inflammatory drugs and opioids, but we know they don’t work well for fibromyalgia. Having a drug whose FDA-approved label indicates it is intended for the treatment of fibromyalgia takes away some of the guessing involved in treating this difficult-to-treat condition.