Posted by MERM on 6/8/2008, 9:34 am
Prospective Fibromyalgia Drug Offers Long Track Record, Few Side Effects
Effirma Begins Process of FDA Approval as a Fibromyalgia Treatment
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).
Pipex Pharmaceuticals hopes to get Effirma approved in the United States for the first time and in April 2008 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. Pipex, 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 has a mild effect on NMDA receptors 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 especially 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.
As of early 2008, Lyrica is the only drug approved for FMS. The FDA nearly rejected Lyrica's application because of the high risk of side effects. Two other drugs, Cymbalta (duloxetine) and milnacipran, are seeking approval as fibromyalgia treatments. The FDA expects to make a decision on Cymbalta by the end of 2008. source aboutchronicfatigue--wellnesstrainresearchtteam!M
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