chronic illness

New Fibromyalgia Treatment on Horizon

Thanks to Amy for this posting this article on her blog!  Yay for some possible helpful meds for fibro!

Prospective Fibromyalgia Drug Offers Long Track Record, Few Side Effects

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-controlledPhase 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.

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. A decision on [and milnacipranis expected by the end of the year.


2008 Pipex Pharmaceuticals, Inc. 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”

2 comments on “New Fibromyalgia Treatment on Horizon

  1. Susan A, Pepe says:

    When will this drug be available in the United States? Any idea

  2. Daniel S Lennox says:

    I don’t know if this is the right section to ask this but I’ll take my chances anyway.
    Hi Jamee, I just want to ask if you ever tried using cannabis for pain management?
    I’ve been suffering with back pain for almost 7 months now and can’t sleep properly at night. I already have a prescription meds but I refrain on using them coz it only take the pain for a minute or so and back again. Then one of my friends gave me a joint to try if it makes me feel better and it does! I try asking him what it is but he has no idea also. So I started doing my own research about medical marijuana and strains that would be effective against pain and came across this
    I’m not sure if that’s the strain that I’ve tried but it has the highest pain management effect. Cbd and thc are all new to me. I also read that drinking it as tea or as a muffin/cake is an option, but is relief effects the same? Why can’t they simply make pills out of marijuana – or maybe there are that I am not aware of. If it’s true, then I would very much appreciate any ideas and advice on what strain is good and how to use it medically. Thanks in advance to those who’ll answer.


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