The newest fibromyalgia (FMS) drug, Savella (milnacipran), won FDA approval 3 years ago this month. We have yet to see a single drug approved for chronic fatigue syndrome (ME/CFS). Will 2012 see a drug come on the market that's proven to be effective for both FMS & ME/CFS?
The drug Northera (droxidopa) is currently before the FDA, and Chelsea Therapeutics requested Priority Review, which means we should hear something from the FDA by March 28. The New Drug Application is for Northera as a treatment for orthostatic hypotension in Parkinson's disease and related conditions, but early studies have shown promise in FMS and ME/CFS.
Orthostatic hypotension causes dizziness upon standing, when the blood pressure drops instead of rising like it's supposed to. This symptom is common in FMS and ME/CFS in addition to Parkinson's. However, studies suggest Northera is also effective against several more symptoms of FMS and ME/CFS. Chelsea announced last month that Phase II trials in fibromyalgia showed success in several key areas, but those data are not yet publicly available.
Northera contains a synthetic form of an ingredient your body uses to make the neurotransmitter/hormone norepinephrine, which is often dysregulated in FMS and ME/CFS. Some of the drugs shown to be most effective at easing symptoms of these conditions alter the levels or function of norepinephrine.
If Northera is approved and comes on the market this year, it'll be available as an off-label treatment for FMS and ME/CFS.
Not much else is in the pipeline for this year. However, 2011 saw promising research for a cancer drug in ME/CFS that will likely spur further work. Also, scientists announced they'd found a way to remove the "high" from marijuana without eliminating the pain-relieving properties. With several studies showing marijuana is effective against FMS pain, I hope we'll see something develop in this area.
Looking ahead to 2013, there's some good financial news - patent protection will expire for the FMS drugs Lyrica (pregabalin) and Cymbalta (duloxetine), meaning inexpensive generic forms could come on the market. A company has already received FDA permission to begin producing and selling generic duloxetine once the protection ends.
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