Fibromyalgia Drugs: Successes or Failures?

In the pharmaceutical industry, they’re known as “blockbuster drugs” – medications that generate billions of dollars in sales and profits for drug makers.

Cymbalta, Lyrica and Savella — the only drugs approved by the Food and Drug Administration to treat fibromyalgia — certainly fit that mold.

In 2013, Cymbalta was the 5th most widely prescribed drug in the United States, generating sales of $5.2 billion for Eli Lilly, according to research firm IMS Health.

Pfizer’s Lyrica was no slouch either, reaching sales of $2.4 billion as the 19th top selling drug. Forest Laboratories’ Savella brought up the rear, with sales of $105 million in 2013.

Cymbalta graphCollectively, with over $7.7 billion in sales, one would think the drugs must be very effective medications. But they’re not, according to a survey of over 1,300 fibromyalgia patients by the National Pain Foundation and National Pain Report.

About two-thirds of those who tried Cymbalta, Lyrica or Savella said they don’t work at all. Only about 10% said the drugs were very effective.

The National Institutes of Health estimates that 5 million Americans suffer from fibromyalgia, a poorly understood disorder characterized by deep tissue pain, fatigue, headaches, depression, and lack of sleep. There is no known cure and the disorder is difficult to treat.

“NOTHING is effective! Each thing just takes the edge off temporarily,” wrote one survey respondent.

Lyrica graph“Lyrica helped a little but gained 39 pounds and still could not tolerate the pain,” said another.

“I had Fibro for 26 years. Nothing has really helped long term. The worst is Lyrica and Cymbalta,” said one fibromyalgia sufferer.

Patients may not be impressed with the medications, but drug makers are. In the pharmaceutical industry, a success rate of just a few percentage points during clinical trials is often called “significant”.

“Ten percent of patients get helped a lot by three different drugs. That’s something!” says Seth Lederman, MD, a rheumatologist who prefers to see the glass as half full, rather than half empty.

“It is a wonderful triumph of the pharmaceutical industry that they have three drugs for fibromyalgia.”

Savella graphDr. Lederman, who began working with fibromyalgia patients in the mid 1980’s, refers to it as the “dark ages” – a time when no drugs were approved for fibromyalgia and the condition wasn’t taken seriously by many physicians.

Today Lederman is the CEO and co-founder of Tonix (NASDAQ: TNXP) – a drug development company that hopes its experimental drug TNX-102 will become the 4th medication to be approved by the FDA for the treatment of fibromyalgia.

“If you’d spoken to people in 2006, 99 percent of the people in the industry, drug developers, weren’t even working on this. They were saying nothing is going to help those (fibromyalgia) patients. We don’t even know what’s wrong with them,” Lederman recalls.

“From my point of view, it was a real watershed moment when the FDA approved Lyrica in 2007. And it’s hard now, looking back, to give it the importance that it had for patients and doctors. Because it introduced the first FDA-approved effective therapy. That was very fulfilling for patients. It took them out of the world of being pariah, crackpot, whining, all of the problems that patients faced before that moment.”

Betsy Jacobson, a longtime activist in the fibromyalgia community, says the dark ages never really ended for fibromyalgia sufferers. She says the pharmaceutical industry has failed to find effective treatments to treat the disorder.

“Very few of any of the meds mentioned really work,” Jacobson wrote in an email to National Pain Report.

“Pharmaceutical companies are constantly trying to find out what works for fibromyalgia. There is only one thing that is important to Big Pharma, and that is their bottom line. It is a very corrupt industry, and if it really wanted to help the patient, it would have found a cure for cancer and other notable diseases with all the billions they’ve spent on research.”

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