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Prospective Fibromyalgia Treatment Offers Long Track Record, Few Side Effects

Effirma Begins Process of FDA Approval as a Fibromyalgia Treatment

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Updated June 08, 2010

A new fibromyalgia drug could be on he horizon, and this one has a long history of use for pain with only mild side effects and no chance of addiction. Effirma (oral flupirtine) is the drug, and it's not an opiate, an antidepressant or an anti-seizure medication, which makes it substantively different from other drugs used to treat fibromyalgia syndrome (FMS).

Adeona Pharmaceuticals hopes to get Effirma approved in the United States for the first time, and in April 2008 the company announced that the U.S. FDA granted it an Investigational New Drug Application. That gives the company permission to conduct a randomized, double-blind, placebo-controlled Phase II clinical trial for Effirma as an FMS treatment.

While it's never been approved in the United States for any use, oral flupirtine has been approved in Europe for more than 25 years. There, it's used to treat pain from several sources, including surgery, cancer, trauma and liver disease. Adeona, however, hopes to show that it treats more than just the pain of FMS, but improves mood, fatigue, cognitive problems, sleep disturbance and overall functionality.

Effirma works differently than conventional pain medications because of the way it targets pain pathways in the brain. Opiates, which are frequently ineffective in people with FMS, raise your level of dopamine, which essentially causes pleasure. Rather than blocking pain, opiates make you care less about the pain.

Effirma, on the other hand, has a mild effect on NMDA receptors in the brain and, as a result, lowers your levels of glutamate, which is a neurotransmitter that makes cells more active. A study, led by prominent FMS researcher Daniel Clauw, MD, shows that people with FMS can have high levels of glutamate and that when glutamate levels drop, so do pain levels. Researchers even suggested that glutamate levels could be used as a biological indication of how severe individual cases are. Clauw's team called for more research to confirm this link, and clinical trials of Effirma could help do that.

People with FMS have an especially hard time tolerating medications. The medications frequently used to treat it, meanwhile, have long lists of side effects and can be especially hard to tolerate. That makes Effirma very attractive, since it has a long track record of being easily tolerated.

In a year-long study on its effect on arthritis, oral flupirtine worked consistently, and without increased dosage, for 75% of the participants. The most common side effects were dizziness (11% of patients), drowsiness (9%), itching (9%) and dry mouth (5%). Also, researchers found that people did not have to wean gradually off of the drug, as you do with most current FMS treatments.

The process for getting drugs approved in the United States is a long one, so even if trials show it is a safe and effective treatment for FMS, it could be years before Effirma is on the market.

The first drug to be FDA approved as a fibromyalgia treatment was Lyrica (pregabalin). The FDA nearly rejected Lyrica's application because of the high risk of side effects. In June 2008, Cymbalta (duloxetine) became the second drug to win approval. In January 2009, the FDA approved Savella (milnacipran) for fibromyalgia.

Sources:

2008 Pipex Pharmaceuticals, Inc. (Now Adeona Pharmaceuticals.) All rights reserved. "Effirma (oral flupirtine)"

Postgraduate Medical Journal. 1987;63 Suppl 3:87-103. All rights reserved. "On the adverse reactions and efficacy of long-term treatment with flupirtine: preliminary results of an ongoing twelve-month study with 200 patients suffering from chronic pain states in arthrosis or arthritis."

2008 University of Michigan. "Pain in fibromyalgia is linked to changes in brain molecule"

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