Major Study Underway for New Fibromyalgia Drug

By Pat Anson, Editor

Lyrica, Cymbalta, and Savella -- the only drugs approved by the U.S. Food and Drug Administration to treat fibromyalgia -- may be getting some competition.

A Japanese drug company, Daiichi Sankyo, is conducting clinical trials on mirogabalin, a new drug that could finally give fibromyalgia sufferers an alternative to the three approved medications -- which often don’t work or have too many side effects.

Daiichi Sankyo is currently enrolling patients in the “ALDAY” study, a large Phase III clinical trial evaluating the safety and efficacy of mirogabalin in treating pain from fibromyalgia. About 4,000 patients will be studied at 800 clinical centers in 40 different countries.

“We need men and women, 18 and older, who have been suffering from fibromyalgia pain for the last 3 months to participate in the ALDAY research study. If you qualify, you will be seen by a study doctor and receive all study-related medications at no cost. Compensation for study-related time and travel may also be available,” the company says on a website promoting the study.

A unique aspect of the ALDAY study is that it pits mirogabalin head to head against Lyrica (pregabalin), the top-selling fibromyalgia medication.  Both drugs bind to calcium channels that are believed to cause neuropathic pain. An earlier Phase II study suggested that mirogabalin may be 17 times more effective than Lyrica, although some critics questioned whether the design of the study was fair.

Advanced trials are also underway in Asia evaluating mirogabalin in the treatment of pain from diabetic peripheral neuralgia and postherpetic neuralgia (shingles).

“Pain associated with the neurologic conditions of diabetic peripheral neuropathic pain, postherpetic neuralgia and fibromyalgia can be debilitating,” said Lesley Arnold, MD, Professor of Psychiatry and Behavioral Neuroscience and Director of the Women’s Health Research Program, University of Cincinnati and lead investigator of the ALDAY program. “New treatment options are needed to help people living with these neurologic conditions relieve and manage their chronic pain and hopefully, improve their function and quality of life.”

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, mood swings, and insomnia. There is no known cure and the disorder is difficult to treat.

Many fibromyalgia sufferers have complained that Lyrica, Cymbalta and Savella – which were originally developed to treat other disorders like epilepsy, anxiety, and depression – are ineffective for fibromyalgia.

“There are far too many off-label prescriptions written. These two classifications, anti-seizure and antidepressant, are frequently prescribed for pain on and off label. They come with far more side effects than opioids, but physicians feel, (and) are told, they are doing the right thing, when we are lacking statistics on after-market deaths associated with them,” said Celeste Cooper, a retired nurse, fibromyalgia sufferer and patient advocate.

“They completely reorder the brain and it is my opinion that these drugs should only be prescribed by physicians who specialize in brain chemistry (psychiatrist and neurologist) and know what interactions and side effects to alert patients, which is not being done currently.”

Dozens of patients wrote to Pain News Network with complaints of side effects from Lyrica and Cymbalta after a recent story about lawsuits involving the drugs.

“I took Cymbalta for a while. It didn't stop the pain of fibromyalgia, it just put 30 lbs. on me. I had my doctor wean me off. I got horrible Brain Zaps for a long time and felt terrible. Never take Cymbalta!” wrote Carol Fruzzetti.

“When I was on Lyrica I was literally walking into walls in my house or holding onto the wall for fear I was going to pass out I would get so dizzy. It made me feel like I was drunk all the time. I did not drive for fear I would kill myself or someone else. I will never take this drug again,” wrote Lana Straten.

Lyrica is one of Pfizer’s top selling drugs, generating $5.1 billion in revenue in 2014.  

Cymbalta generated annual sales of $5 billion for Eli Lilly until its patent expired in 2013 and cheaper generic versions of Doluxetine became available.

Savella generated sales of “only” $105 million for Forest Laboratories in 2013.