New drug, Savella, brings hope for fibromyalgia patients

Hard to define and even harder to treat, fibromyalgia has become one of the most controversial medical conditions of the past quarter-century. Affecting an estimated 5.8 million Americans, it has been recognized as a disease by the American Medical Association since 1987. But because its most significant symptoms are pain and fatigue, with no obvious cause, FM patients — most of whom are women — can sometimes find that they're not taken seriously even by some medical professionals.

St. Petersburg geriatrician and fibromyalgia expert Dr. Mildred Farmer says there's new hope on the horizon for FM sufferers. Meridien Research, the company she co-founded in 1990, was one of the institutions that tested the efficacy and safety of a new fibromyalgia medication called Savella that was recently approved by the FDA and should be on the market later this year. It's just the third anti-FM medication approved by the FDA, following Cymbalta and Lyrica.

Savella is already being prescribed in Europe as an antidepressant, but Meridien Research and other test sites across the country were looking at how it could help FM sufferers by affecting norepinephrine, a central nervous system neurotransmitter.

Neither Farmer nor her company has a financial interest in Savella or the company that makes it, Cypress Bioscience.

What is fibromyalgia?

Essentially, it's a collection of symptoms, a pain syndrome that is otherwise non-specific. Some people have aches and pains and not much fatigue, and some people have mostly the chronic fatigue and not as much pain. It could spring from a variety of causes.

How can you diagnose something that's so elusive?

You must have widespread pain, in all four quadrants of the body, and it must be chronic. It's characterized by the presence of trigger points. When you press on one of these points, they cause pain. It's the presence of these trigger points and widespread pain, and the absence of joint and muscle pain, that makes fibromyalgia. It can be very subtle, and you might not even know you have it.

Who's most likely to suffer from fibromyalgia?

It's more common in women than men, and nobody knows why. I've read estimates that the ratio is 9 to 1. I wouldn't be able to verify that, but it's in that ballpark. Most of my fibromyalgia patients had a pain incident that preceded it — a car accident, a blow to the head. My usual patient is someone who has had back surgery. There's also a genetic component, but it's not just one gene, it's a combination of genes.

How has it traditionally been treated?

What's been happening for a long time is that rheumatologists have been treating fibromyalgia as a muscular-skeletal condition, and now it's recognized as neuro-muscular. Traditional pain medications don't do much. Non-steroidal anti-inflammatories, muscle relaxants, tricyclic antidepressants and exercise have all been somewhat effective, but different patients respond to different treatments. Even though the antidepressants can work, fibromyalgia is not depression. The patient may feel depressed, because of the chronic pain and because maybe no one believes her, but antidepressants can be effective for fibromyalgia itself.

Is Savella a dramatic breakthrough or just one more weapon in the arsenal?

In a way it's just one more weapon. But the anti-fibromyalgia arsenal is so incredibly limited that even one additional weapon is significant.

What's different about Savella?

Savella has more norepinephrine activity, and antidepressants with more norepinephrine activity seem to be more effective in treating pain. But there's not been a head-to-head comparison of Cymbalta and this drug, so we can't say this is better.